Excelsior Medical Corp.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Excelsior Medical Corp.” (first 1995, latest 2014), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 187 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 | 1 | 260 |
| 2014 | 2 | 227 |
| 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 |
|---|---|---|---|
| NGT | Saline, Vascular Access Flush | 3 | 3 |
| NZW | Heparin, Vascular Access Flush | 3 | 3 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| QBP | Cap, Device Disinfectant | 2 | 2 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
Review panels
- General Hospital (11)
Most recent Excelsior Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142620 | 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe | NGT | 2014-12-12 | 87 |
| K133446 | HEPARIN LOCK / FLUSH SYRINGES | NZW | 2014-11-14 | 367 |
| K130975 | SWABCAP AND SWABFLUSH | QBP | 2013-12-24 | 260 |
| K101270 | SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 | NGT | 2011-02-10 | 280 |
| K083508 | SWABCAP | QBP | 2009-04-28 | 153 |
| K082837 | STERILE FIELD SALINE PRE-FILLED SYRINGE(S) | NGT | 2008-12-18 | 83 |
| K061497 | SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML | NZW | 2007-02-23 | 268 |
| K053120 | STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES | FOZ | 2005-12-09 | 32 |
| K023740 | SYREX PRE-FILLED SYRINGE | NZW | 2003-05-13 | 187 |
| K962938 | EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) | FOZ | 1996-10-25 | 88 |
1 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2016-04-28.
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.
- Excelsior Resources, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Excelsior Medical Corp.?
FDA lists 11 510(k) clearances under the applicant name “Excelsior Medical Corp.” (first 1995, latest 2014), across 5 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 Excelsior Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Excelsior Medical Corp. is 187 days.
Which FDA product codes appear under Excelsior Medical Corp.?
The most frequent FDA product codes under this applicant name are NGT (Saline, Vascular Access Flush, 3); NZW (Heparin, Vascular Access Flush, 3); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 2).
Next steps
- See all 11 Excelsior Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code NGT, Excelsior Medical Corp.'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.