Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pall Medical · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
318 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033991 | MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET | Pall Medical | 2004-01-22 | 30 | 0 |
| K030469 | LAPAROSHIELD CONDITIONED INSUFFLATION SET | Pall Medical | 2003-05-09 | 86 | 0 |
| K013093 | PALL ULTIPOR ANESTHESIA BREATHING SYSTEM | Pall Medical | 2002-08-01 | 318 | 0 |
| K992361 | PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL | Pall Medical | 1999-08-20 | 36 | 0 |
| K983735 | PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING | Pall Medical | 1999-01-07 | 77 | 0 |
| K983731 | PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING | Pall Medical | 1998-12-21 | 60 | 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