Koi, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Koi, Inc.” (first 1981, latest 1986), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 25 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 |
|---|---|---|---|
| HNN | Knife, Ophthalmic | 2 | 2 |
| HKL | Retinoscope, Ac-Powered | 1 | 1 |
| HMX | Cannula, Ophthalmic | 1 | 1 |
| HNW | Dilator, Lachrymal | 1 | 1 |
| HOE | Caliper, Ophthalmic | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
Review panels
- Ophthalmic (6)
- Radiology (1)
Most recent Koi, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K843247 | KOI PACHYMETER | ITX | 1986-04-30 | 618 |
| K830366 | DIAMOND KNIFE | HNN | 1983-03-09 | 33 |
| K812764 | KOI BLUE FIELD ENTOPTOSCOPE | HKL | 1981-12-02 | 61 |
| K812450 | KOI DIAMOND KNIFE | HNN | 1981-09-21 | 24 |
| K812097 | KOI LACREMAL HOOK & DILATOR | HNW | 1981-08-18 | 25 |
| K812011 | BLADE GAUGE | HOE | 1981-07-28 | 11 |
| K812010 | KOI LACRIMAL INTUBATION SYSTEM | HMX | 1981-07-28 | 11 |
Recalls
openFDA lists no recalls under a recalling firm named Koi, 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 Koi, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Koi, Inc.” (first 1981, latest 1986), across 6 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 Koi, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Koi, Inc. is 25 days.
Which FDA product codes appear under Koi, Inc.?
The most frequent FDA product codes under this applicant name are HNN (Knife, Ophthalmic, 2); HKL (Retinoscope, Ac-Powered, 1); HMX (Cannula, Ophthalmic, 1).
Next steps
- See all 7 Koi, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HNN, Koi, 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.