Allegiance Healthcare Corp.: FDA filings under this applicant name
FDA lists 64 510(k) clearances under 2 spellings of the applicant name “Allegiance Healthcare Corp.” (first 1996, latest 2003), across 24 product codes in 6 review panels. Median 510(k) review time under this name: 48 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Cardinal Health, based on public ownership records.
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 |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 9 | 9 |
| KKX | Drape, Surgical, Antimicrobial | 9 | 9 |
| FYA | Gown, Surgical | 8 | 8 |
| LYY | Latex Patient Examination Glove | 8 | 8 |
| FRG | Wrap, Sterilization | 5 | 5 |
| DXC | Clamp, Vascular | 3 | 3 |
| IMD | Pack, Hot Or Cold, Disposable | 3 | 3 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 2 | 2 |
| LZA | Polymer Patient Examination Glove | 2 | 2 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
Plus 14 more product codes.
Review panels
- General Hospital (47)
- Anesthesiology (6)
- General and Plastic Surgery (4)
- Cardiovascular (3)
- Physical Medicine (3)
- Gastroenterology and Urology (1)
Most recent Allegiance Healthcare Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023673 | AIRLIFE DEMAND NASAL CANNULA | NFB | 2003-05-02 | 182 |
| K023602 | SMALL VOLUME NEBULIZER | CAF | 2003-05-01 | 185 |
| K023419 | TRILAMINATE DRAPES/TIBURON | KKX | 2003-02-11 | 123 |
| K024120 | MODIFICATION TO TEMNO BIOPSY NEEDLES | FCG | 2003-01-15 | 30 |
| K024292 | MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM | LYY | 2003-01-09 | 16 |
| K024102 | DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM | LYY | 2002-12-18 | 6 |
| K023425 | DRAPES WITH ABSORBENT REINFORCEMENT | KKX | 2002-11-06 | 26 |
| K022765 | NITRILE POWDER-FREE EXAMINATION GLOVES | LZA | 2002-10-11 | 52 |
| K023170 | NITRILE POWDER-FREE EXAMINATION GLOVES | LZA | 2002-10-09 | 16 |
| K023167 | BREATHABLE SURGICAL GOWN | FYA | 2002-10-02 | 9 |
54 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-01-22.
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 Allegiance Healthcare Corp. (a text match, not an official crosswalk):
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Allegiance Healthcare Corp. (63)
- Allegiance Healthcare Corporation (1)
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.
- Allegiance Healthcare Coporation (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Allegiance Healthcare Corp.?
FDA lists 64 510(k) clearances under 2 spellings of the applicant name “Allegiance Healthcare Corp.” (first 1996, latest 2003), across 24 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 Allegiance Healthcare Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Allegiance Healthcare Corp. is 48 days.
Which FDA product codes appear under Allegiance Healthcare Corp.?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 9); KKX (Drape, Surgical, Antimicrobial, 9); FYA (Gown, Surgical, 8).
Next steps
- See all 64 Allegiance Healthcare Corp. clearances with predicates and recalls
- Run predicate analysis for product code KGO, Allegiance Healthcare 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 (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.