Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stan-Pak Ent. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
24 daysmedian FDA review time
50 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K823058 | DOSOMETRIC RELEASE STERILIZATION | Stan-Pak Ent. | 1982-12-09 | 52 | 0 |
| K820100 | FROSTED GLASS SLIDES | Stan-Pak Ent. | 1982-03-04 | 50 | 0 |
| K820099 | TRACH TAPE | Stan-Pak Ent. | 1982-02-23 | 41 | 0 |
| K820108 | TOPPER SPONGES | Stan-Pak Ent. | 1982-02-12 | 28 | 0 |
| K820140 | WEBRIL CAST PADDING | Stan-Pak Ent. | 1982-02-12 | 24 | 0 |
| K820155 | SPECIALIST CAST PADDING | Stan-Pak Ent. | 1982-02-12 | 24 | 0 |
| K820107 | GUAZE SPONGES, PLAIN | Stan-Pak Ent. | 1982-02-12 | 28 | 0 |
| K820106 | X-RAY GUAZE SPONGES | Stan-Pak Ent. | 1982-02-12 | 28 | 0 |
| K820141 | BIAS STOCKINETTE | Stan-Pak Ent. | 1982-02-05 | 17 | 0 |
| K820056 | TELFA STRIPS | Stan-Pak Ent. | 1982-02-05 | 25 | 0 |
| K820142 | TUBULAR STOCKINETTE | Stan-Pak Ent. | 1982-02-05 | 17 | 0 |
| K820139 | SOF-ROL CAST PADDING | Stan-Pak Ent. | 1982-02-05 | 17 | 0 |
| K820105 | COMBINE PAD OR ABD | Stan-Pak Ent. | 1982-02-05 | 21 | 0 |
| K820053 | KERLIX FLUFFS | Stan-Pak Ent. | 1982-02-04 | 24 | 0 |
| K820097 | SHEET WADDING CAST PADDING | Stan-Pak Ent. | 1982-02-04 | 22 | 0 |
| K820052 | SAFETY PINS | Stan-Pak Ent. | 1982-02-04 | 24 | 0 |
| K820096 | VAG PACKING | Stan-Pak Ent. | 1982-02-04 | 22 | 0 |
| K820095 | TONSIL SPONGES | Stan-Pak Ent. | 1982-02-04 | 22 | 0 |
| K820098 | ROLLER GAUZE | Stan-Pak Ent. | 1982-02-04 | 22 | 0 |
| K820094 | ELASTIC BANDAGE | Stan-Pak Ent. | 1982-01-29 | 16 | 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