Phoenix Biomedical Corp.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under 2 spellings of the applicant name “Phoenix Biomedical Corp.” (first 1996, latest 2004), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | 11 | 11 |
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | 1 | 1 |
| MKY | System, Skin Closure | 1 | 1 |
Review panels
- Neurology (11)
- General and Plastic Surgery (2)
Most recent Phoenix Biomedical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033017 | PHOENIX INFUSION CATHETER | JXG | 2004-04-07 | 194 |
| K030468 | ACURA ELITE GRAVITY COMPENSATING RESERVOIR | JXG | 2003-10-15 | 245 |
| K024101 | PHOENIX UNIVERSAL SHUNT SYSTEM | JXG | 2003-01-27 | 46 |
| K024040 | ACCURA ELITE SHUNT SYSTEM | JXG | 2003-01-27 | 52 |
| K021644 | PERF (OMMAYA STYLE) RESERVOIRS | JXG | 2002-08-06 | 78 |
| K002476 | LUMBOPERITONEAL SHUNT SYSTEM | JXG | 2000-11-09 | 90 |
| K000514 | RUMBAR DRAINAGE SYSTEM | JXG | 2000-05-10 | 84 |
| K991429 | DIAMOND II VALVE | JXG | 1999-05-19 | 23 |
| K990256 | CRX WORLD SHUNT | JXG | 1999-04-01 | 64 |
| K974096 | CRX DIAMOND VALVE | JXG | 1998-12-08 | 404 |
3 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: 2004-01-06.
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.
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:
- Phoenix Biomedical Corp. (12)
- Phoenix Biomedical (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.
- Phoenix Diagnostics, Inc. (21 510(k)s)
- Phoenix Medical Technology, Inc. (11 510(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 Biomedical Corp.?
FDA lists 13 510(k) clearances under 2 spellings of the applicant name “Phoenix Biomedical Corp.” (first 1996, latest 2004), across 3 product codes in 2 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 Biomedical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Phoenix Biomedical Corp. is 90 days.
Which FDA product codes appear under Phoenix Biomedical Corp.?
The most frequent FDA product codes under this applicant name are JXG (Shunt, Central Nervous System And Components, 11); GAS (Suture, Nonabsorbable, Synthetic, Polyester, 1); MKY (System, Skin Closure, 1).
Next steps
- See all 13 Phoenix Biomedical Corp. clearances with predicates and recalls
- Run predicate analysis for product code JXG, Phoenix Biomedical 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.