Pneupac , Ltd.: FDA clearances and approvals
Pneupac , Ltd. has 20 FDA 510(k) clearances (first 1980, latest 2004), across 4 product codes in 2 review panels. Median 510(k) review time: 64 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 8 | 8 |
| CBK | Ventilator, Continuous, Facility Use | 7 | 7 |
| DRM | Compressor, Cardiac, External | 4 | 4 |
| BTI | Compressor, Air, Portable | 1 | 1 |
Review panels
- Anesthesiology (16)
- Cardiovascular (4)
Most recent Pneupac , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040090 | COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS) | BTL | 2004-05-27 | 132 |
| K030803 | PARAPAC 200D TRANSPORT, MODEL V200D | BTL | 2003-09-29 | 200 |
| K021841 | COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER | BTL | 2003-07-17 | 407 |
| K020899 | PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D | BTL | 2002-12-13 | 268 |
| K970158 | BABYPAC | CBK | 1998-04-28 | 467 |
| K960515 | PARAPAC | BTL | 1996-10-10 | 248 |
| K863410 | PATIENT VALVE WITH AIR ENTRAINMENT | BTL | 1987-01-12 | 173 |
| K862830 | MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR | BTL | 1986-10-15 | 84 |
| K843737 | PNEUPAC INSTANT ACTION VENTILATOR/RESUS | CBK | 1984-10-04 | 9 |
| K832700 | PNEU PAC VENTILATOR/RESUSCITATORS | CBK | 1983-11-14 | 96 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pneupac , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Pneupac , Ltd. have?
Pneupac , Ltd. has 20 FDA 510(k) clearances (first 1980, latest 2004), across 4 product codes in 2 review panels.
How long does FDA take to clear Pneupac , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Pneupac , Ltd.'s cleared 510(k)s is 64 days.
What devices does Pneupac , Ltd. make?
Its most frequent FDA product codes are BTL (Ventilator, Emergency, Powered (Resuscitator), 8); CBK (Ventilator, Continuous, Facility Use, 7); DRM (Compressor, Cardiac, External, 4).
Has Pneupac , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Pneupac , Ltd. Related entities may recall under other names.
Next steps
- See all 20 Pneupac , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BTL, Pneupac , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.