Mira, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Mira, Inc.” (first 1984, latest 1997), across 14 product codes in 5 review panels. Median 510(k) review time under this name: 71 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 |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 4 | 4 |
| HQF | Laser, Ophthalmic | 4 | 4 |
| FFS | Image, Illumination, Fiberoptic, For Endoscope | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| HLI | Ophthalmoscope, Ac-Powered | 1 | 1 |
| HNR | Forceps, Ophthalmic | 1 | 1 |
| HPO | Magnet, Ac-Powered | 1 | 1 |
| HPS | Unit, Cryophthalmic | 1 | 1 |
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | 1 | 1 |
| HQT | Shell, Scleral | 1 | 1 |
Plus 4 more product codes.
Review panels
- Ophthalmic (15)
- Gastroenterology and Urology (1)
- General Hospital (1)
- Orthopedic (1)
- Clinical Toxicology (1)
Most recent Mira, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951728 | SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE | HLI | 1997-03-19 | 706 |
| K950806 | SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS | HQX | 1996-06-05 | 469 |
| K941495 | RETURN PATH DIATHERMY HANDLE | HQR | 1994-07-15 | 109 |
| K933527 | MODIFICATION OF ANTERIOR SEGMENT ELECTRODES | HWA | 1994-01-25 | 189 |
| K923629 | OPHTHALMIC TRICHIASIS PROBE | HPS | 1992-10-19 | 90 |
| K894248 | CONVERTER SYSTEM | HQE | 1990-02-27 | 251 |
| K891601 | POWER OPERATED AND CONTROLLED VITREOUS SCISSORS | HQE | 1989-05-23 | 64 |
| K890448 | LIGHT SOURCE, ENDOSCOP, XENON ARC | FFS | 1989-05-08 | 101 |
| K863246 | MIRALITE | HQF | 1986-10-31 | 70 |
| K863591 | ENDOPHOTOCOAGULATION PROBE | HQF | 1986-10-10 | 25 |
11 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2010-04-08.
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 Mira, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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.
- Mira Lasers, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mira, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Mira, Inc.” (first 1984, latest 1997), across 14 product codes in 5 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 Mira, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mira, Inc. is 71 days.
Which FDA product codes appear under Mira, Inc.?
The most frequent FDA product codes under this applicant name are HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 4); HQF (Laser, Ophthalmic, 4); FFS (Image, Illumination, Fiberoptic, For Endoscope, 1).
Next steps
- See all 21 Mira, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQE, Mira, 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.