Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Seamless Hospital Products Co. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
116 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841769 | INTERMITTENT URETHRAL CATHETER TRAY | Seamless Hospital Products Co. | 1984-08-24 | 116 | 0 |
| K823061 | BRUSH, SCRUB, OPERATING ROOM | Seamless Hospital Products Co. | 1982-11-05 | 18 | 0 |
| K821134 | DC PACK TM | Seamless Hospital Products Co. | 1982-06-22 | 63 | 0 |
| K820490 | IV START TRAY | Seamless Hospital Products Co. | 1982-03-16 | 21 | 0 |
| K781127 | CONNECTING TUBE, CONDUCTIVE, SURG. | Seamless Hospital Products Co. | 1978-09-20 | 77 | 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