Excel Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Excel Medical, Inc.” (first 1991, latest 1993), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 163 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | 4 | 4 |
| FRN | Pump, Infusion | 1 | 1 |
Review panels
- General Hospital (5)
Most recent Excel Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932462 | VENTED NEEDLE | LHI | 1993-09-15 | 117 |
| K923966 | SYRINGE ADAPTOR | LHI | 1993-06-18 | 315 |
| K914988 | 500 INFUSER | FRN | 1992-04-06 | 152 |
| K913804 | EXCELSIOR SINGLE LEAD DISPENSING SET | LHI | 1992-02-11 | 169 |
| K905116 | PHARM-ASSIST | LHI | 1991-04-25 | 163 |
Recalls
openFDA lists no recalls under a recalling firm named Excel Medical, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Excel Medical, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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 Health Care Products (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 Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Excel Medical, Inc.” (first 1991, latest 1993), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Excel Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Excel Medical, Inc. is 163 days.
Which FDA product codes appear under Excel Medical, Inc.?
The most frequent FDA product codes under this applicant name are LHI (Set, I.V. Fluid Transfer, 4); FRN (Pump, Infusion, 1).
Next steps
- See all 5 Excel Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LHI, Excel Medical, 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.