Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sterile Concepts, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
256 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K951231 | ORTHOPEDIC PACKS | Sterile Concepts, Inc. | 1995-12-01 | 256 | 0 |
| K951081 | OB/GYN PACKS | Sterile Concepts, Inc. | 1995-11-13 | 249 | 0 |
| K952539 | RADIOLOGY PACKS | Sterile Concepts, Inc. | 1995-07-14 | 44 | 0 |
| K951478 | GENERAL AND PLASTIC SURGERY PACKS | Sterile Concepts, Inc. | 1995-06-13 | 75 | 0 |
| K944139 | DENTAL HYGIENE TRAY | Sterile Concepts, Inc. | 1994-12-15 | 113 | 0 |
| K943047 | IV START KITS | Sterile Concepts, Inc. | 1994-09-14 | 79 | 0 |
| K943090 | SUTURE REMOVAL TRAYS | Sterile Concepts, Inc. | 1994-08-22 | 55 | 0 |
| K940864 | DENTIST WITH ASSISTANT PACK | Sterile Concepts, Inc. | 1994-08-02 | 160 | 0 |
| K943046 | SKIN STAPLE REMOVAL TRAYS | Sterile Concepts, Inc. | 1994-07-29 | 32 | 0 |
| K920763 | LACERATTION TRAY | Sterile Concepts, Inc. | 1992-09-28 | 222 | 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