Indigo Medical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Indigo Medical, Inc.” (first 1996, latest 1999), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 116 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 5 | 5 |
| KXK | Source, Brachytherapy, Radionuclide | 1 | 1 |
Review panels
Most recent Indigo Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992262 | INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM | KXK | 1999-10-04 | 90 |
| K990851 | INDIGO LASEROPTIC TREATMENT SYSTEM | GEX | 1999-03-30 | 15 |
| K963969 | INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10 WATTS) INDIGO FIB | GEX | 1997-12-23 | 446 |
| K963081 | INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS | GEX | 1997-02-21 | 197 |
| K955758 | INDIGO MEDICAL MODEL IDL 830E | GEX | 1996-02-16 | 59 |
| K954195 | INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS | GEX | 1996-01-25 | 141 |
Recalls
openFDA lists no recalls under a recalling firm named Indigo Medical, 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.
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.
- Indigo Orb, Inc. (1 510(k)s)
- INDIGO TECHNOLOGIES (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Indigo Medical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Indigo Medical, Inc.” (first 1996, latest 1999), across 2 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 Indigo Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Indigo Medical, Inc. is 116 days.
Which FDA product codes appear under Indigo Medical, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 5); KXK (Source, Brachytherapy, Radionuclide, 1).
Next steps
- See all 6 Indigo Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Indigo Medical, 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.