Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cottrell, Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
784 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972708 | ENDO-SPOR PLUS / HYPROCIDE | Cottrell, Ltd. | 1999-09-13 | 784 | 0 |
| K970726 | VAPOCIDE | Cottrell, Ltd. | 1998-05-18 | 444 | 0 |
| K960089 | PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR | Cottrell, Ltd. | 1996-04-04 | 84 | 0 |
| K952241 | PROTOUCH OVERGLOVE | Cottrell, Ltd. | 1995-08-07 | 87 | 0 |
| K952234 | BARRIER ALL FILM | Cottrell, Ltd. | 1995-07-31 | 80 | 0 |
| K932922 | PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR | Cottrell, Ltd. | 1995-07-03 | 748 | 0 |
| K951983 | IMNI-II | Cottrell, Ltd. | 1995-06-20 | 54 | 0 |
| K945575 | PRO BARRIER(TM) TUBE SOX(TM) | Cottrell, Ltd. | 1995-03-06 | 112 | 0 |
| K893802 | PROVIEW SELF-SEALING STERILIZATION POUCH | Cottrell, Ltd. | 1990-04-04 | 317 | 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