Pall Medical: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Pall Medical” (first 1998, latest 2004), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 68 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | 2 | 2 |
| HIF | Insufflator, Laparoscopic | 2 | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| FYD | Apparatus, Exhaust, Surgical | 1 | 1 |
Review panels
- Dental (2)
- General Hospital (2)
- Obstetrics and Gynecology (2)
Most recent Pall Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033991 | MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET | HIF | 2004-01-22 | 30 |
| K030469 | LAPAROSHIELD CONDITIONED INSUFFLATION SET | HIF | 2003-05-09 | 86 |
| K013093 | PALL ULTIPOR ANESTHESIA BREATHING SYSTEM | CAH | 2002-08-01 | 318 |
| K992361 | PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1 | FYD | 1999-08-20 | 36 |
| K983735 | PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE | EIA | 1999-01-07 | 77 |
| K983731 | PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE | EIA | 1998-12-21 | 60 |
Recalls
openFDA lists no recalls under a recalling firm named Pall Medical.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Pall Biomedical Products Co. (28 510(k)s)
- Pall Corp. (4 510(k)s)
- Pall International Sarl (2 510(k)s)
- Pall Safety Atmospheres, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pall Medical?
FDA lists 6 510(k) clearances under the applicant name “Pall Medical” (first 1998, latest 2004), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pall Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pall Medical is 68 days.
Which FDA product codes appear under Pall Medical?
The most frequent FDA product codes under this applicant name are EIA (Unit, Operative Dental, 2); HIF (Insufflator, Laparoscopic, 2); CAH (Filter, Bacterial, Breathing-Circuit, 1).
Next steps
- See all 6 Pall Medical clearances with predicates and recalls
- Run predicate analysis for product code EIA, Pall Medical's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.