American White Cross, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “American White Cross, Inc.” (first 1985, latest 1997), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 50 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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | 2 | 2 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| FPX | Strip, Adhesive, Closure, Skin | 1 | 1 |
| KMF | Bandage, Liquid | 1 | 1 |
| LWF | Dilator, Nasal | 1 | 1 |
| NAD | Dressing, Wound, Occlusive | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent American White Cross, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964614 | ULTRAFERA WOUND DRESSING | KMF | 1997-02-06 | 80 |
| K962400 | AIR MAX EXTERNAL NASAL DILATOR STRIP | LWF | 1996-09-09 | 80 |
| K894802 | AWC BUTTERFLY WOUND CLOSURES | FPX | 1990-01-31 | 187 |
| K854809 | WHITE CROSS STERILE PAD 4IN. X 4IN. | — | 1986-01-13 | 41 |
| K853558 | DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ | — | 1985-09-05 | 10 |
| K853334 | NON-ADHERA ADHESIVE PAD 3X4 | NAD | 1985-08-21 | 12 |
| K852412 | NON-ADHERENT PAD | EFQ | 1985-07-29 | 53 |
| K852408 | EXTRA LARGE ADHESIVE STRIPS | KGX | 1985-07-29 | 53 |
| K852462 | TRICOT ADHESIVE BANDAGE | KGX | 1985-07-26 | 46 |
| K850595 | 3 X 4 NON-ADHERENT PAD | — | 1985-03-11 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named American White Cross, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American White Cross, Inc.?
FDA lists 10 510(k) clearances under the applicant name “American White Cross, Inc.” (first 1985, latest 1997), across 7 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 American White Cross, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American White Cross, Inc. is 50 days.
Which FDA product codes appear under American White Cross, Inc.?
The most frequent FDA product codes under this applicant name are KGX (Tape And Bandage, Adhesive, 2); EFQ (Gauze/Sponge, Internal, 1); FPX (Strip, Adhesive, Closure, Skin, 1).
Next steps
- See all 10 American White Cross, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KGX, American White Cross, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.