A Plus International, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “A Plus International, Inc.” (first 1988, latest 2022), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 24 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 233 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name A Plus International, Inc. took a median 233 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 153 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FXX | Mask, Surgical | 2 | 2 |
| FYF | Cap, Surgical | 2 | 2 |
| KKX | Drape, Surgical, Antimicrobial | 2 | 2 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| FXO | Suit, Surgical | 1 | 1 |
| FXP | Cover, Shoe, Operating-Room | 1 | 1 |
| FYA | Gown, Surgical | 1 | 1 |
| FYC | Gown, Isolation, Surgical | 1 | 1 |
Review panels
Most recent A Plus International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213001 | Procedure Mask, Surgical Mask | FXX | 2022-05-11 | 233 |
| K102861 | SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE) | KKX | 2011-01-13 | 105 |
| K093169 | SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) | FYA | 2009-11-12 | 36 |
| K031353 | SOLUTION FACE MASKS | FXX | 2003-06-19 | 51 |
| K882284 | SURGEONS CAP | FYF | 1988-06-23 | 23 |
| K882283 | BOUFFANT CAP | FYF | 1988-06-23 | 23 |
| K882282 | SUIT, SURGICAL | FXO | 1988-06-23 | 23 |
| K882281 | GOWN, ISOLATION, SURGICAL (FYC) | FYC | 1988-06-23 | 23 |
| K882280 | COVER, SHOE OPERATING ROOM | FXP | 1988-06-23 | 23 |
| K881396 | OPERATING ROOM TOWELS -STERILE & NON-STERILE | KKX | 1988-04-29 | 25 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named A Plus International, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under A Plus International, Inc.?
FDA lists 11 510(k) clearances under the applicant name “A Plus International, Inc.” (first 1988, latest 2022), across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by A Plus International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name A Plus International, Inc. is 24 days.
Which FDA product codes appear under A Plus International, Inc.?
The most frequent FDA product codes under this applicant name are FXX (Mask, Surgical, 2); FYF (Cap, Surgical, 2); KKX (Drape, Surgical, Antimicrobial, 2).
Next steps
- See all 11 A Plus International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FXX, A Plus International, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.