Apex Medical Corp.: FDA filings under this applicant name
FDA lists 36 510(k) clearances under 2 spellings of the applicant name “Apex Medical Corp.” (first 1987, latest 2022), across 13 product codes in 6 review panels. Median 510(k) review time under this name: 133 days. Since 2017 the median was 255 days, against 159 days for all cleared 510(k)s in the same product codes. 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 | 2 | 318 |
| 2013 | 1 | 367 |
| 2014 | 1 | 119 |
| 2015 | 1 | 238 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 255 |
| 2020 | 1 | 344 |
| 2021 | 0 | — |
| 2022 | 1 | 230 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Apex Medical Corp. took a median 255 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 159 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 12 | 12 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 8 | 8 |
| CAF | Nebulizer (Direct Patient Interface) | 3 | 3 |
| IPF | Stimulator, Muscle, Powered | 3 | 3 |
| GXY | Electrode, Cutaneous | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 | 1 |
| ILX | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat | 1 | 1 |
Plus 3 more product codes.
Review panels
- Anesthesiology (16)
- Neurology (10)
- Physical Medicine (4)
- General and Plastic Surgery (3)
- General Hospital (2)
- Cardiovascular (1)
Most recent Apex Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213577 | VenAir, Sequential Compression System | JOW | 2022-06-28 | 230 |
| K193206 | WiZARD 510 Nasal Mask | BZD | 2020-10-29 | 344 |
| K182394 | WiZARD 310/320 Series CPAP Mask | BZD | 2019-05-17 | 255 |
| K150111 | Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series | BZD | 2015-09-15 | 238 |
| K141522 | APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES | BZD | 2014-10-06 | 119 |
| K121642 | WIZARD 230 NASAL PILOW MASK | BZD | 2013-06-06 | 367 |
| K112079 | APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 | BZD | 2012-12-06 | 504 |
| K120035 | APEX MEDICAL ICH CPAP SERIES (9S-007XXX) | BZD | 2012-05-16 | 133 |
| K103174 | APEX MEDICAL WIZARD SERIES CPAP MASK | BZD | 2011-05-06 | 191 |
| K103535 | VACPLUS SUCTION UNIT | JCX | 2011-02-24 | 85 |
26 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Apex Medical Corp..
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 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:
- Apex Medical Corp. (30)
- Apex Medical, Inc. (6)
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 BioTechnology Corp. (35 510(k)s)
- Apex Dental Materials, Inc. (15 510(k)s)
- Apex Medical Technologies, Inc. (8 510(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 Corp.?
FDA lists 36 510(k) clearances under 2 spellings of the applicant name “Apex Medical Corp.” (first 1987, latest 2022), across 13 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 Apex Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Apex Medical Corp. is 133 days. Since 2017: 255 days, versus 159 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Apex Medical Corp.?
The most frequent FDA product codes under this applicant name are BZD (Ventilator, Non-Continuous (Respirator), 12); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 8); CAF (Nebulizer (Direct Patient Interface), 3).
Next steps
- See all 36 Apex Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code BZD, Apex 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 (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.