← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

DRT — Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

DEVICE CLASS
Class II
REGULATION
21 CFR 870.2300
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K261286Circadia Health, Inc. · 510k2026-05-20
K252676Circadia Health, Inc. · 510k2026-02-03
K253388Sleepiz AG · 510k2026-01-28
K251364Sleepiz AG · 510k2025-07-29

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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