FDA PRODUCT CODE · CLASS II
LDR — Controller, Infusion, Intravascular, Electronic
What these counts are not
Clearance and recall counts are SPEQ’s aggregation of FDA’s own published records for the code. A recall count is a measure of history, not of a device’s safety, neither number is an FDA rating, and SPEQ is not affiliated with the FDA.
What this classification requires
Every statement below is FDA’s own classification record for this product code, quoted from the device classification field reference. The SPEQ reading beneath each one is SPEQ’s interpretation of what it means for the work, and is not FDA text.
510(K)
SPEQ READINGA premarket notification under 21 CFR Part 807 Subpart E is the route for this code. The submission argues substantial equivalence to a legally marketed predicate, so the engineering question is which predicate the design can actually be compared against, and the evidence question is what testing supports that comparison.
Class II (moderate to high risk): general controls and special controls
SPEQ READINGSpecial controls are the distinguishing feature: performance standards, guidance documents, patient registries or postmarket surveillance named for the device type. Find the special controls before designing the test plan — they usually name the tests.
Device is eligible for The Voluntary Malfunction Summary Reporting Program
SPEQ READINGMalfunctions for this code may be reported in periodic summary form rather than as individual MDRs under 21 CFR Part 803. Eligibility is a property of the product code; using it is a decision the manufacturer makes and must be able to justify.
Not exempt due to Good Manufacturing Practice (GMP)/Quality System
SPEQ READINGThe full Quality Management System Regulation (21 CFR 820, incorporating ISO 13485:2016) applies, and is what an FDA inspection of this device will be conducted against.
Device is not implantable
SPEQ READINGNo implant-specific expectations attach from the classification itself.
Device is not used for life sustaining purposes
SPEQ READINGNo life-sustaining designation attaches to this code.
Device is not a candidate for a third party review program
SPEQ READINGFDA reviews any premarket notification for this code directly.
Other product codes under 21 CFR 880.5725
One regulation usually governs several product codes. These share this code’s regulation, and therefore its classification basis.
21 CFR 880.5725 — Infusion pump
The classification regulation for this product code, as published by the Office of the Federal Register. This is the regulation text itself — no SPEQ interpretation appears in it.
(a) Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
(b) Classification. Class II (performance standards).
Source: Electronic Code of Federal Regulations, Title 21. 21 CFR is a work of the United States Government and is in the public domain. SPEQ read this section on October 22, 2026. CFR is amended continuously, so verify against the source before acting on it: read 21 CFR 880.5725 on eCFR →
Recent clearances
Recent recalls
ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the devi
ConMed received 16 complaints for STAT 2 Pumpette devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that the STAT 2 Pumpette Compensating Controller on several complaint samples had been assembled incorrect
ConMed received 16 complaints for STAT 2 Pumpette devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that the STAT 2 Pumpette Compensating Controller on several complaint samples had been assembled incorrect
Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
Source: FDA device classification, 510(k)/PMA, and recall datasets. Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. Browse every product code SPEQ tracks →