Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pneupac , Ltd. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
268 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040090 | COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 PO | Pneupac , Ltd. | 2004-05-27 | 132 | 0 |
| K030803 | PARAPAC 200D TRANSPORT, MODEL V200D | Pneupac , Ltd. | 2003-09-29 | 200 | 0 |
| K021841 | COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER | Pneupac , Ltd. | 2003-07-17 | 407 | 0 |
| K020899 | PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P | Pneupac , Ltd. | 2002-12-13 | 268 | 0 |
| K960515 | PARAPAC | Pneupac , Ltd. | 1996-10-10 | 248 | 0 |
| K863410 | PATIENT VALVE WITH AIR ENTRAINMENT | Pneupac , Ltd. | 1987-01-12 | 173 | 0 |
| K862830 | MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR | Pneupac , Ltd. | 1986-10-15 | 84 | 0 |
| K843737 | PNEUPAC INSTANT ACTION VENTILATOR/RESUS | Pneupac , Ltd. | 1984-10-04 | 9 | 0 |
| K832700 | PNEU PAC VENTILATOR/RESUSCITATORS | Pneupac , Ltd. | 1983-11-14 | 96 | 0 |
| K820220 | VENTILATOR MODELS | Pneupac , Ltd. | 1982-02-18 | 22 | 0 |
| K792456 | PNEUPAC VENTILATOR/RESUSCITATOR #3 | Pneupac , Ltd. | 1980-02-05 | 64 | 0 |
| K792457 | COMPRESSOR | Pneupac , Ltd. | 1980-02-05 | 64 | 0 |
| K792451 | PNEUPAC RESUSCITATOR INSTANT ACTION SET | Pneupac , Ltd. | 1980-02-05 | 64 | 0 |
| K792458 | PNEUPAC TEST SET, PT.#500-A250 | Pneupac , Ltd. | 1980-02-05 | 64 | 0 |
| K792455 | PNEUPAC VENTILATOR/RESUSCITATOR #2 | Pneupac , Ltd. | 1980-02-05 | 64 | 0 |
| K792453 | PNEUPAC OXYGEN THERAPY UNIT | Pneupac , Ltd. | 1980-02-05 | 64 | 0 |
| K792454 | PNEUPAC RESUSCITATOR INSTANT ACTION SET | Pneupac , Ltd. | 1980-02-05 | 64 | 0 |
| K792459 | PNEUPAC VENTILATOR/RESUSCITATOR | Pneupac , Ltd. | 1980-02-05 | 64 | 0 |
| K792452 | PNEUPAC RESUSCITATOR INSTANT ACTION SET | Pneupac , Ltd. | 1980-02-05 | 64 | 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