Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bemis Mfg. Co. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
126 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K020921 | NO-POKES NEEDLE SAFETY DEVICE | Bemis Mfg. Co. | 2002-07-11 | 112 | 0 |
| K965248 | BEMIS TWO GALLON SHARPS CONTAINER | Bemis Mfg. Co. | 1997-02-14 | 72 | 1 |
| K964858 | BEMIS TWO GALLON CHEMOTHERAPY CONTAINER | Bemis Mfg. Co. | 1997-02-11 | 69 | 0 |
| K960525 | BEMIS ONE QUART PHLEBOTOMY CONTAINER (PART NUMBER 100) | Bemis Mfg. Co. | 1996-03-28 | 52 | 0 |
| K953797 | SHARPS DISPOSAL CONTAINERS | Bemis Mfg. Co. | 1995-11-27 | 108 | 0 |
| K950340 | IGHT AND ELEVEN GALLON SHARPS AND CHEMOTHERAPY CONTAINERS | Bemis Mfg. Co. | 1995-06-02 | 126 | 0 |
| K941664 | SHARP DISPOSAL CONTAINERS WALL SAFE | Bemis Mfg. Co. | 1994-05-23 | 77 | 1 |
| K931664 | SHARPS DISPOSABLE CONTAINERS | Bemis Mfg. Co. | 1994-05-23 | 413 | 1 |
| K941665 | SHARPS DISPOSAL CONTAINER/PHLEBOTOMY | Bemis Mfg. Co. | 1994-05-23 | 77 | 0 |
| K914601 | SUCTION CONNECTING TUBING | Bemis Mfg. Co. | 1992-02-07 | 119 | 0 |
| K911576 | CHEMOTHERAPY CONTAINER | Bemis Mfg. Co. | 1991-07-05 | 88 | 0 |
| K852335 | STERILIZATION CONTAINER | Bemis Mfg. Co. | 1985-09-16 | 108 | 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