Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pall Biomedical Products Co. — Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
233 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954331 | PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) | Pall Biomedical Products Co. | 1997-01-09 | 482 | 0 |
| K960993 | PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) | Pall Biomedical Products Co. | 1996-04-22 | 41 | 1 |
| K905794 | PALL 3N1 FILTER | Pall Biomedical Products Co. | 1991-06-13 | 168 | 1 |
| K902518 | LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE | Pall Biomedical Products Co. | 1990-10-16 | 132 | 1 |
| K884534 | PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER | Pall Biomedical Products Co. | 1989-01-24 | 88 | 0 |
| K875095 | PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE | Pall Biomedical Products Co. | 1988-02-29 | 81 | 0 |
| K875094 | ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE | Pall Biomedical Products Co. | 1988-02-29 | 81 | 0 |
| K873667 | PALL LEUKOCYTE REMOVAL FILTER, PLATELETS | Pall Biomedical Products Co. | 1988-01-06 | 118 | 0 |
| K873666 | PALL LEUKOCYTE REMOVAL FILTER, BLOOD | Pall Biomedical Products Co. | 1988-01-06 | 118 | 0 |
| K874405 | PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE | Pall Biomedical Products Co. | 1987-12-30 | 63 | 0 |
| K853987 | PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE | Pall Biomedical Products Co. | 1985-12-11 | 75 | 0 |
| K854062 | PALL PULMONARY FUNCTION FILTER | Pall Biomedical Products Co. | 1985-11-07 | 34 | 0 |
| K850825 | AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR | Pall Biomedical Products Co. | 1985-04-09 | 40 | 0 |
| K850826 | POSIDYNE SOLUTION CONTAINER FILTER, RECORDER #96 | Pall Biomedical Products Co. | 1985-04-09 | 40 | 0 |
| K850327 | PALL GAS LINE GUARDIAN FILTER | Pall Biomedical Products Co. | 1985-02-26 | 29 | 0 |
| K834382 | PALL EC PLUS FILTER W/FILTER SLEEVE | Pall Biomedical Products Co. | 1984-08-03 | 233 | 0 |
| K842141 | SOLUTION CLARIFICATION UNIT | Pall Biomedical Products Co. | 1984-08-03 | 65 | 0 |
| K834380 | PALL EC PLUS FILTER | Pall Biomedical Products Co. | 1984-08-03 | 233 | 0 |
| K834381 | POSIDYNE I.V. FILTER/AIR ELIMINATOR | Pall Biomedical Products Co. | 1984-04-24 | 133 | 0 |
| K834292 | PALL HEAT MOISTURE EXCHANGING FILTER | Pall Biomedical Products Co. | 1984-04-04 | 118 | 0 |
| K840960 | PALL COALESCER | Pall Biomedical Products Co. | 1984-03-16 | 10 | 0 |
| K831882 | POSIDYNE SOLUTION CONTAINER FILTER | Pall Biomedical Products Co. | 1983-09-20 | 99 | 0 |
| K831286 | ULTIPORE PREBYPASS PLUS FILTER | Pall Biomedical Products Co. | 1983-06-08 | 49 | 0 |
| K812505 | PALL ULTIPOR VACUUM LINE BACTERIA FITLER | Pall Biomedical Products Co. | 1981-09-16 | 15 | 0 |
| K811985 | ULTIPOR SQ40S BLOOD TRANSFUSION FILTER | Pall Biomedical Products Co. | 1981-07-28 | 15 | 0 |
| K791748 | ULTIPOR BLOOD FILTER EXTRA-CORPOREAL | Pall Biomedical Products Co. | 1979-10-02 | 22 | 0 |
| K791307 | UNIPOR BREATHING CIRCUIT FILTER | Pall Biomedical Products Co. | 1979-08-03 | 18 | 1 |
| K790879 | ULTIPOR SOLUTION CONTAINER FILTER | Pall Biomedical Products Co. | 1979-06-01 | 25 | 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