Excel Health Care Products: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Excel Health Care Products” (first 1985, latest 1986), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 33 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 3 | 3 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 | 1 |
Review panels
Most recent Excel Health Care Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K850960 | NON-ABSORBENT DRAPES & ABSORBENT TOWELS | KKX | 1986-03-15 | 372 |
| K850456 | TRACHEOSTOMY CARE KIT | BTO | 1985-03-11 | 33 |
| K850326 | STERILE FILM DRAPE FENESTRATED W/ADHESIVE PATCH | KKX | 1985-02-26 | 29 |
| K850325 | STERILE SUTURE REMOVAL KIT | KDD | 1985-02-26 | 29 |
| K850199 | POLY-LINED TOWEL/DRAPE LINE | KKX | 1985-02-21 | 34 |
Recalls
openFDA lists no recalls under a recalling firm named Excel Health Care Products.
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.
- Excel Tech. , Ltd. (58 510(k)s)
- Excel Scientific, Inc. (8 510(k)s)
- Excel Medical, Inc. (5 510(k)s)
- Excel U.S.A. (3 510(k)s)
- Excel Medical Products, Inc. (2 510(k)s)
- Excel Mobility Products, Inc. (2 510(k)s)
- Excel Eyewear Corp. (1 510(k)s)
- Excel Glove Co., Ltd. (1 510(k)s)
- Excel Medical Electronics, LLC (1 510(k)s)
- Excel Medical Systems, Inc. (1 510(k)s)
- Excel Porcelain Products (1 510(k)s)
- Excel Rubber Products (M) Sdn. Bhd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Excel Health Care Products?
FDA lists 5 510(k) clearances under the applicant name “Excel Health Care Products” (first 1985, latest 1986), across 3 product codes in 3 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 Excel Health Care Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Excel Health Care Products is 33 days.
Which FDA product codes appear under Excel Health Care Products?
The most frequent FDA product codes under this applicant name are KKX (Drape, Surgical, Antimicrobial, 3); BTO (Tube, Tracheostomy (W/Wo Connector), 1); KDD (Kit, Surgical Instrument, Disposable, 1).
Next steps
- See all 5 Excel Health Care Products clearances with predicates and recalls
- Run predicate analysis for product code KKX, Excel Health Care Products'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.