Ipax, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Ipax, Inc.” (first 1984, latest 2021), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 64 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 | 1 | 396 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ipax, Inc. took a median 396 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 225 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 7 | 7 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| GAD | Retractor | 2 | 2 |
| MML | Weights, Eyelid, External | 2 | 2 |
| GBQ | Catheter, Continuous Irrigation | 1 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
| KMK | Device, Intravascular Catheter Securement | 1 | 1 |
| LHI | Set, I.V. Fluid Transfer | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Ipax, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200893 | ProntoPump Sterile Tube Set | LHI | 2021-05-04 | 396 |
| K971242 | BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) | MML | 1997-12-17 | 259 |
| K971245 | BLINK EXTERNAL EYELID WEIGHT | MML | 1997-06-20 | 78 |
| K915158 | SUREBREATH DOME, E-Z BREATHER | GAD | 1992-02-12 | 90 |
| K915118 | PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE | HQC | 1991-12-27 | 44 |
| K914221 | KPE 220 TS, NONSTERILE | HQE | 1991-10-25 | 63 |
| K914172 | KPE 230 AM | HQC | 1991-10-25 | 60 |
| K884076 | SUREBREATH DOME | GAD | 1988-10-07 | 10 |
| K873097 | PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS | GBQ | 1987-09-04 | 39 |
| K870770 | TIMLEINE(TM) VENIPUNCTURE SYSTEM | KMK | 1987-04-23 | 56 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ipax, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ipax, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Ipax, Inc.” (first 1984, latest 2021), across 9 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 Ipax, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ipax, Inc. is 64 days.
Which FDA product codes appear under Ipax, Inc.?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 7); FPA (Set, Administration, Intravascular, 2); GAD (Retractor, 2).
Next steps
- See all 18 Ipax, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQC, Ipax, 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.