Pall Biomedical Products Co.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Pall Biomedical Products Co.” (first 1979, latest 1997), across 10 product codes in 5 review panels. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| FPB | Filter, Infusion Line | 7 | 7 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 5 | 5 |
| CAK | Microfilter, Blood Transfusion | 4 | 4 |
| CAH | Filter, Bacterial, Breathing-Circuit | 3 | 3 |
| KRJ | Filter, Prebypass, Cardiopulmonary Bypass | 3 | 3 |
| JOD | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass | 2 | 2 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 | 1 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 1 | 1 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 1 | 1 |
Review panels
- General Hospital (14)
- Cardiovascular (10)
- Anesthesiology (2)
- Clinical Chemistry (1)
- Hematology (1)
Most recent Pall Biomedical Products Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954331 | PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) | FPB | 1997-01-09 | 482 |
| K960993 | PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) | CAK | 1996-04-22 | 41 |
| K905794 | PALL 3N1 FILTER | FPB | 1991-06-13 | 168 |
| K902518 | LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE | DTM | 1990-10-16 | 132 |
| K884534 | PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER | JPA | 1989-01-24 | 88 |
| K875095 | PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE | JOD | 1988-02-29 | 81 |
| K875094 | ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE | KRJ | 1988-02-29 | 81 |
| K873667 | PALL LEUKOCYTE REMOVAL FILTER, PLATELETS | CAK | 1988-01-06 | 118 |
| K873666 | PALL LEUKOCYTE REMOVAL FILTER, BLOOD | CAK | 1988-01-06 | 118 |
| K874405 | PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE | JOD | 1987-12-30 | 63 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pall Biomedical Products Co..
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 Medical (6 510(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 Biomedical Products Co.?
FDA lists 28 510(k) clearances under the applicant name “Pall Biomedical Products Co.” (first 1979, latest 1997), across 10 product codes in 5 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 Biomedical Products Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pall Biomedical Products Co. is 70 days.
Which FDA product codes appear under Pall Biomedical Products Co.?
The most frequent FDA product codes under this applicant name are FPB (Filter, Infusion Line, 7); DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line, 5); CAK (Microfilter, Blood Transfusion, 4).
Next steps
- See all 28 Pall Biomedical Products Co. clearances with predicates and recalls
- Run predicate analysis for product code FPB, Pall Biomedical Products Co.'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.