Apex Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Apex Medical Technologies, Inc.” (first 1987, latest 2012), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 162 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 | 1 | 301 |
| 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 |
|---|---|---|---|
| HIS | Condom | 3 | 3 |
| HHE | Cup, Menstrual | 1 | 1 |
| KGO | Surgeon'S Gloves | 1 | 1 |
| LIO | Device, Specimen Collection | 1 | 1 |
| MEB | Pump, Infusion, Elastomeric | 1 | 1 |
| MOL | Condom, Synthetic | 1 | 1 |
Review panels
Most recent Apex Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112165 | RHEA CUP | HHE | 2012-05-24 | 301 |
| K060933 | SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM | MEB | 2006-05-09 | 34 |
| K954791 | SEMINAL FLUID COLLECTION KIT II | HIS | 1996-01-05 | 79 |
| K922688 | EXTRA PROTECTION POLYURETHANE CONDOM | MOL | 1995-05-04 | 1064 |
| K930313 | APEX SPECIMEN BAG | LIO | 1993-03-18 | 55 |
| K902936 | POLYURETHANE CONDOM | HIS | 1991-03-06 | 246 |
| K871358 | SENSATIONS BRAND CONDOMS | HIS | 1989-03-01 | 695 |
| K874539 | HI-TOUCH (TM) BRAND SURGICAL GLOVES | KGO | 1987-12-14 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Apex Medical Technologies, 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 Apex Medical Technologies, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MEB)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MEB)
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.
- Apex Medical Corp. (36 510(k)s)
- Apex BioTechnology Corp. (35 510(k)s)
- Apex Dental Materials, Inc. (15 510(k)s)
- Apex Surgical, LLC (6 510(k)s)
- Apex Metal, Inc. (3 510(k)s)
- Apex Tools & Orthopedics Co. (2 510(k)s)
- Apex Ent., Inc. (1 510(k)s)
- Apex Imaging Corp. (1 510(k)s)
- Apex Medical Products, LLC (1 510(k)s)
- Apex Optical Ind. Co. (1 510(k)s)
- Apex Orthodontics, Inc. (1 510(k)s)
- Apex Technologies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Apex Medical Technologies, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Apex Medical Technologies, Inc.” (first 1987, latest 2012), across 6 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 Apex Medical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Apex Medical Technologies, Inc. is 162 days.
Which FDA product codes appear under Apex Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are HIS (Condom, 3); HHE (Cup, Menstrual, 1); KGO (Surgeon'S Gloves, 1).
Next steps
- See all 8 Apex Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Apex Medical Technologies, 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 (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.