Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
A Plus International, Inc. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
24 daysmedian FDA review time
105 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213001 | Procedure Mask, Surgical Mask | A Plus International, Inc. | 2022-05-11 | 233 | 0 |
| K102861 | SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLU | A Plus International, Inc. | 2011-01-13 | 105 | 0 |
| K093169 | SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), R | A Plus International, Inc. | 2009-11-12 | 36 | 0 |
| K031353 | SOLUTION FACE MASKS | A Plus International, Inc. | 2003-06-19 | 51 | 0 |
| K882282 | SUIT, SURGICAL | A Plus International, Inc. | 1988-06-23 | 23 | 0 |
| K882281 | GOWN, ISOLATION, SURGICAL (FYC) | A Plus International, Inc. | 1988-06-23 | 23 | 0 |
| K882284 | SURGEONS CAP | A Plus International, Inc. | 1988-06-23 | 23 | 0 |
| K882280 | COVER, SHOE OPERATING ROOM | A Plus International, Inc. | 1988-06-23 | 23 | 0 |
| K882283 | BOUFFANT CAP | A Plus International, Inc. | 1988-06-23 | 23 | 0 |
| K881396 | OPERATING ROOM TOWELS -STERILE & NON-STERILE | A Plus International, Inc. | 1988-04-29 | 25 | 0 |
| K881395 | GAUZE AND LAP SPONGES -STERILE & NON-STERILE | A Plus International, Inc. | 1988-04-28 | 24 | 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