Iop, Inc.: FDA clearances and approvals
Iop, Inc. has 9 FDA 510(k) clearances (first 1989, latest 2009), across 5 product codes in 1 review panel. Median 510(k) review time: 90 days.
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 |
|---|---|---|---|
| KYF | Implant, Eye Valve | 3 | 3 |
| MML | Weights, Eyelid, External | 2 | 2 |
| NXM | Prosthesis, Eyelid Spacer/Graft, Biologic | 2 | 2 |
| HPZ | Implant, Eye Sphere | 1 | 1 |
| NFM | Expander, Tissue, Orbital | 1 | 1 |
Review panels
- Ophthalmic (9)
Most recent Iop, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090078 | KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT | NXM | 2009-05-08 | 116 |
| K062252 | MOLTENO3 | KYF | 2006-09-27 | 55 |
| K053622 | SURGISIS OCULAR GRAFT | NXM | 2006-03-15 | 77 |
| K010852 | OSMED TISSUE EXPANDER | NFM | 2001-08-13 | 145 |
| K003646 | SUTUREGROOVE WEIGHT SIZING SET | MML | 2001-02-22 | 87 |
| K994289 | SUTUREGROOVE | MML | 2000-04-17 | 118 |
| K972143 | MOA BONE / M-SPHERE | HPZ | 1997-10-16 | 132 |
| K902489 | MODIFIED MOLTENO(TM) IMPLANTS | KYF | 1990-08-14 | 90 |
| K890598 | MOLTENO IMPLANT | KYF | 1989-02-27 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Iop, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Iop, Inc. have?
Iop, Inc. has 9 FDA 510(k) clearances (first 1989, latest 2009), across 5 product codes in 1 review panel.
How long does FDA take to clear Iop, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Iop, Inc.'s cleared 510(k)s is 90 days.
What devices does Iop, Inc. make?
Its most frequent FDA product codes are KYF (Implant, Eye Valve, 3); MML (Weights, Eyelid, External, 2); NXM (Prosthesis, Eyelid Spacer/Graft, Biologic, 2).
Has Iop, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Iop, Inc. Related entities may recall under other names.
Next steps
- See all 9 Iop, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KYF, Iop, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.