Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Physio-Control Corp. — Predicate Candidate Screening
80 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
273 days90th percentile
80clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991910 | LIFEPAK 12 BIPHASIC | Physio-Control Corp. | 1999-09-03 | 88 | 3 |
| K990338 | NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIB | Physio-Control Corp. | 1999-09-01 | 210 | 1 |
| K983393 | LIFEPAK 500 BIPHASIC | Physio-Control Corp. | 1999-05-05 | 222 | 1 |
| K973486 | LIFE PAK 12 | Physio-Control Corp. | 1998-01-09 | 116 | 3 |
| K962359 | LIFEPAK 300 | Physio-Control Corp. | 1997-11-06 | 505 | 0 |
| K955854 | LIFEPAK 500 | Physio-Control Corp. | 1996-11-04 | 312 | 2 |
| K953204 | PEDIATRIC QUIK-COMBO | Physio-Control Corp. | 1996-01-11 | 189 | 0 |
| K951593 | LIFEPAK 11 | Physio-Control Corp. | 1995-12-29 | 267 | 1 |
| K945511 | LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 C | Physio-Control Corp. | 1995-09-26 | 321 | 0 |
| K943301 | QUIK COMBO | Physio-Control Corp. | 1995-02-03 | 210 | 0 |
| K941970 | FAST-PATCH | Physio-Control Corp. | 1994-12-07 | 229 | 0 |
| K925936 | LIFEPAK 300 AUTOMATIC ADVISORY DEFRILLATOR | Physio-Control Corp. | 1994-06-08 | 579 | 0 |
| K922315 | VITAL-COMBO(R) | Physio-Control Corp. | 1994-03-16 | 667 | 0 |
| K935674 | LIFEPAK 9 DEFIBRILLATOR/MONITOR | Physio-Control Corp. | 1993-12-16 | 8 | 0 |
| K931053 | LIFEPAK 10 DEFIBRILLATOR/MONITOR W/OPT PACEMAKER | Physio-Control Corp. | 1993-05-18 | 71 | 0 |
| K912966 | PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG | Physio-Control Corp. | 1992-02-21 | 228 | 0 |
| K912189 | LIKEPAK 11 CARDIAC MONIT/LIFENET RS100 REC STATION | Physio-Control Corp. | 1992-02-14 | 273 | 0 |
| K912599 | QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC | Physio-Control Corp. | 1991-09-11 | 93 | 0 |
| K910144 | 12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON | Physio-Control Corp. | 1991-07-17 | 184 | 0 |
| K902288 | MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR | Physio-Control Corp. | 1991-02-25 | 279 | 2 |
| K905510 | LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED | Physio-Control Corp. | 1990-12-20 | 13 | 0 |
| K902478 | LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR | Physio-Control Corp. | 1990-10-31 | 149 | 0 |
| K895379 | LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES) | Physio-Control Corp. | 1990-02-26 | 180 | 1 |
| K894540 | TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000 | Physio-Control Corp. | 1989-10-12 | 84 | 0 |
| K892005 | SHOCK ADVISORY ADAPTER FOR USE W/LIFEPAK 9 | Physio-Control Corp. | 1989-06-20 | 84 | 0 |
| K892065 | LIFEPAK 250 DEFIBRILLATOR/MONITOR | Physio-Control Corp. | 1989-06-05 | 67 | 0 |
| K890079 | LIFEPAK 10 DEFIBRILLATOR/MONITOR | Physio-Control Corp. | 1989-02-23 | 50 | 1 |
| K883617 | LIFEPAK 50 MONITOR/DEFIBRILLATOR | Physio-Control Corp. | 1988-12-28 | 126 | 0 |
| K883121 | QUIK-PACE II ELECTRODES | Physio-Control Corp. | 1988-09-20 | 56 | 0 |
| K881153 | LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITOR | Physio-Control Corp. | 1988-07-27 | 132 | 1 |
| K881346 | LIFESTAT 1600 PRINTER | Physio-Control Corp. | 1988-06-09 | 71 | 0 |
| K880554 | VSM(R) R2 PAPER CHART RECORDER | Physio-Control Corp. | 1988-05-06 | 87 | 0 |
| K871751 | QUIK-PACE NONINVASIVE PACEMAKER | Physio-Control Corp. | 1987-12-29 | 235 | 0 |
| K871224 | FAST-PATCH(TM) | Physio-Control Corp. | 1987-05-20 | 54 | 0 |
| K864665 | MODIFIED VSM 2 VITAL SIGNS MONITOR | Physio-Control Corp. | 1986-12-11 | 10 | 0 |
| K864666 | MODIFIED LIFESTAT 200 | Physio-Control Corp. | 1986-12-11 | 10 | 0 |
| K853561 | LIFESTAT 100 | Physio-Control Corp. | 1986-06-09 | 287 | 0 |
| K855027 | PULSE OXIMETER | Physio-Control Corp. | 1986-05-16 | 151 | 0 |
| K853096 | CMS 8000 | Physio-Control Corp. | 1986-01-22 | 183 | 0 |
| K854117 | AMENDMENT LIFEPAK 8, NPN 052 | Physio-Control Corp. | 1986-01-13 | 96 | 0 |
| K853732 | LIFEPAK 8 MODIFICATION | Physio-Control Corp. | 1985-12-09 | 94 | 0 |
| K853564 | LIFEPAK 200 | Physio-Control Corp. | 1985-10-11 | 46 | 0 |
| K852322 | VSM-5 | Physio-Control Corp. | 1985-09-11 | 104 | 0 |
| K851916 | VSM MODELS A & B | Physio-Control Corp. | 1985-08-19 | 109 | 0 |
| K851248 | AMENDMENT LIFEPAK 100, NPN 045 | Physio-Control Corp. | 1985-04-19 | 43 | 0 |
| K851247 | AMENDMENT LIFEPAK 200, NPN 046 | Physio-Control Corp. | 1985-04-19 | 43 | 0 |
| K842213 | VSM R1 | Physio-Control Corp. | 1984-10-26 | 144 | 0 |
| K843229 | LIFEPAK 200 | Physio-Control Corp. | 1984-10-18 | 62 | 0 |
| K842624 | LIFEPAK 8 | Physio-Control Corp. | 1984-10-18 | 105 | 0 |
| K840047 | LIFEPAK 7D | Physio-Control Corp. | 1984-02-04 | 29 | 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