Product code DRL— Cardiovascular
CARDIAC CARE Q/C TEST KIT
- Classification name
- Tester, Defibrillator
- Device class
- Class 2
- Regulation
- 21 CFR 870.5325
- Advisory panel
- Cardiovascular
- Total cleared
- 19
- First cleared
- Most recent
Market context for product code DRL
FDA has cleared devices under product code DRL between 1978 and 2019, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2019
- 2018
- 2015
- 2011
- 2008
- 2007
- 2003
- 1997
- 1996
- 1995
- 1994
- 1993
- 1991
- 1990
- 1988
Top applicants under product code DRL
Recent clearances under product code DRL
- K190437 — Delta 3300
- K182905 — UniPulse
- K153210 — Defibrillator Analyzer Variable Load
- K110192 — DEFIBRILLATOR ANALYZER - DA-2006P
- K083347 — IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS
- K072114 — IMPULSE 6000D/7000DP
- K062099 — PHASE 3, MODEL DT-1
- K030547 — MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE
- K963190 — QA-40M DEFIBRILLATOR TESTER
- K961595 — DEFIBRILLATOR ANALYZER, DELTA 1000
- K954391 — MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER
- K941404 — IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER
- K934254 — IMPULSE 3000 DEFIBRILLATOR ANALYZER
- K904159 — DEFIBRILLATOR ANALYZER MODEL QED-5
- K896985 — ZAP-GUARD
- K895525 — MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER
- K880780 — HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG
- K790394 — DEFIBRILLATOR INTERAL PADDLE TEST LOAD
- K782033 — CARDIAC CARE Q/C TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.