Anago, Inc.: FDA filings under this applicant name
FDA lists 44 510(k) clearances under the applicant name “Anago, Inc.” (first 1979, latest 1993), across 21 product codes in 6 review panels. Median 510(k) review time under this name: 34 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 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FXX | Mask, Surgical | 7 | 7 |
| MMK | Container, Sharps | 5 | 5 |
| KKX | Drape, Surgical, Antimicrobial | 4 | 4 |
| IMD | Pack, Hot Or Cold, Disposable | 3 | 3 |
| KME | Bedding, Disposable, Medical | 3 | 3 |
| CAZ | Anesthesia Conduction Kit | 2 | 2 |
| FYF | Cap, Surgical | 2 | 2 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 2 | 2 |
| BTX | Board, Arm (With Cover), Sterile | 1 | 1 |
| BWP | Shoe And Shoe Cover, Conductive | 1 | 1 |
Plus 11 more product codes.
Review panels
- General Hospital (26)
- General and Plastic Surgery (7)
- Physical Medicine (3)
- Anesthesiology (2)
- Gastroenterology and Urology (1)
- Radiology (1)
Most recent Anago, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925659 | U.C.E.Z. LENS CLEANER KIT | OCT | 1993-09-17 | 345 |
| K930161 | ANAGO SPINAL ANESTHESIA TRAY | CAZ | 1993-07-06 | 174 |
| K926590 | ANAGO DISPOSABLE INSTANT COLD PACK | IMD | 1993-05-26 | 170 |
| K926589 | ANAGO WARM PACK | IMD | 1993-05-26 | 170 |
| K926137 | ANAGO FEM-COOL/FEM-COOL PETITE | IMD | 1993-05-26 | 170 |
| K920615 | ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT | CAZ | 1993-03-20 | 403 |
| K915415 | GUARDALL SHIELD | LYU | 1992-10-15 | 321 |
| K913558 | RELIABLE CONE STYLE FACE MASK | FXX | 1991-11-07 | 90 |
| K905865 | ANTI-FOR SURGICAL FACE MASK | FXX | 1991-03-06 | 72 |
| K905749 | SURGICAL FACE MASK | FXX | 1991-03-04 | 70 |
34 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Anago, 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 Anago, Inc.?
FDA lists 44 510(k) clearances under the applicant name “Anago, Inc.” (first 1979, latest 1993), across 21 product codes in 6 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 Anago, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Anago, Inc. is 34 days.
Which FDA product codes appear under Anago, Inc.?
The most frequent FDA product codes under this applicant name are FXX (Mask, Surgical, 7); MMK (Container, Sharps, 5); KKX (Drape, Surgical, Antimicrobial, 4).
Next steps
- See all 44 Anago, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FXX, Anago, 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.