Phoenix Medical Technology, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Phoenix Medical Technology, Inc.” (first 1986, latest 2000), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 71 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 5 | 5 |
| LYZ | Vinyl Patient Examination Glove | 3 | 3 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
Review panels
Most recent Phoenix Medical Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000223 | NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE | LZA | 2000-04-14 | 81 |
| K945045 | PATIENT EXAINATION GLOVES | LYY | 1995-01-02 | 80 |
| K905031 | PATIENT EXAMINATION GLOVES | LYZ | 1991-01-18 | 72 |
| K900454 | MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVES | LYY | 1990-02-13 | 14 |
| K900453 | MODIFIED SINGLE USE LATEX EXAMINATION GLOVES | LYY | 1990-02-13 | 14 |
| K890917 | PHOENIX DRAPES WITH MICROBAN | KGX | 1989-08-17 | 175 |
| K892976 | SINGLE USE VINYL EXAM GLOVES - COLOR CODED | LYZ | 1989-06-22 | 71 |
| K892975 | LOW POWDER SINGLE USE LATEX EXAM GLOVES | LYY | 1989-06-19 | 68 |
| K891949 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | 1989-05-25 | 58 |
| K891132 | PATIENT EXAMINATION GLOVE | LYZ | 1989-03-22 | 19 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Phoenix Medical Technology, 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.
- Phoenix Diagnostics, Inc. (21 510(k)s)
- Phoenix Biomedical Corp. (13 510(k)s)
- Phoenix Glove Co. (6 510(k)s)
- Phoenix Dental, Inc. (5 510(k)s)
- Phoenix Bioengineering, Inc. (3 510(k)s)
- Phoenix Biotech Corp. (2 510(k)s)
- Phoenix Imaging (2 510(k)s)
- Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. (2 510(k)s)
- Phoenix Corp. (1 510(k)s)
- Phoenix Instruments Div. (1 510(k)s)
- Phoenix Intl. Marketing, Inc. (1 510(k)s)
- Phoenix Laser Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Phoenix Medical Technology, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Phoenix Medical Technology, Inc.” (first 1986, latest 2000), across 5 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 Phoenix Medical Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Phoenix Medical Technology, Inc. is 71 days.
Which FDA product codes appear under Phoenix Medical Technology, Inc.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 5); LYZ (Vinyl Patient Examination Glove, 3); DRX (Electrode, Electrocardiograph, 1).
Next steps
- See all 11 Phoenix Medical Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Phoenix Medical Technology, 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.