Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DRL — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
98 daysmedian FDA review time
230 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190437 | Delta 3300 | Netech Corporation | 2019-08-28 | 187 | 0 |
| K182905 | UniPulse | Seaward Group | 2018-12-14 | 59 | 0 |
| K153210 | Defibrillator Analyzer Variable Load | Bc Group International, Inc. | 2015-12-21 | 46 | 0 |
| K110192 | DEFIBRILLATOR ANALYZER - DA-2006P | Bc Group International, Inc. | 2011-02-08 | 15 | 1 |
| K083347 | IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS | Fluke Biomedical | 2008-12-24 | 41 | 0 |
| K072114 | IMPULSE 6000D/7000DP | Fluke Biomedical | 2008-01-28 | 180 | 0 |
| K062099 | PHASE 3, MODEL DT-1 | Datrend Systems, Inc. | 2007-01-25 | 185 | 0 |
| K030547 | MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE | Guardian Angel Products, Inc. | 2003-07-11 | 141 | 0 |
| K963190 | QA-40M DEFIBRILLATOR TESTER | Metron U.S., Inc. | 1997-07-01 | 320 | 0 |
| K961595 | DEFIBRILLATOR ANALYZER, DELTA 1000 | Netech Corp. | 1996-10-29 | 188 | 0 |
| K954391 | MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL | Bio-Tek Instruments, Inc. | 1995-11-17 | 59 | 0 |
| K941404 | IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER | Hogan & Hartson | 1994-06-29 | 98 | 0 |
| K934254 | IMPULSE 3000 DEFIBRILLATOR ANALYZER | Dynatech/Nevada, Inc. | 1993-11-23 | 84 | 0 |
| K904159 | DEFIBRILLATOR ANALYZER MODEL QED-5 | Bio-Tek Instruments, Inc. | 1991-03-18 | 188 | 0 |
| K896985 | ZAP-GUARD | Guardian Angel Products, Inc. | 1990-07-31 | 230 | 0 |
| K895525 | MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER | Matrix Medica, Inc. | 1990-01-26 | 136 | 0 |
| K880780 | HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG | First Medical Devices Corp. | 1988-05-12 | 76 | 0 |
| K790394 | DEFIBRILLATOR INTERAL PADDLE TEST LOAD | Physio-Control Corp. | 1979-03-23 | 25 | 0 |
| K782033 | CARDIAC CARE Q/C TEST KIT | Instrumentation Laboratory CO | 1978-12-15 | 9 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda