Retinalabs.Com: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Retinalabs.Com” (first 2000, latest 2000), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| HMX | Cannula, Ophthalmic | 1 | 1 |
| KYG | Device, Irrigation, Ocular Surgery | 1 | 1 |
| MPA | Endoilluminator | 1 | 1 |
| MRH | Pump, Infusion, Ophthalmic | 1 | 1 |
| NDC | Calculator, Drug Dose | 1 | 1 |
Review panels
- Ophthalmic (4)
- Clinical Chemistry (1)
Most recent Retinalabs.Com 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003036 | TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 | KYG | 2000-12-22 | 84 |
| K000418 | PDT DOSECALCULATOR, MODEL 80000 | NDC | 2000-10-24 | 259 |
| K000457 | VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES | HMX | 2000-05-09 | 88 |
| K000420 | SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 | MRH | 2000-05-08 | 90 |
| K000416 | TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 | MPA | 2000-05-08 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Retinalabs.Com.
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 Retinalabs.Com (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MRH)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRH)
Frequently asked questions
How many FDA 510(k) clearances are listed under Retinalabs.Com?
FDA lists 5 510(k) clearances under the applicant name “Retinalabs.Com” (first 2000, latest 2000), across 5 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 Retinalabs.Com?
The median time from FDA receipt to decision across 510(k)s cleared under the name Retinalabs.Com is 90 days.
Which FDA product codes appear under Retinalabs.Com?
The most frequent FDA product codes under this applicant name are HMX (Cannula, Ophthalmic, 1); KYG (Device, Irrigation, Ocular Surgery, 1); MPA (Endoilluminator, 1).
Next steps
- See all 5 Retinalabs.Com clearances with predicates and recalls
- Run predicate analysis for product code HMX, Retinalabs.Com'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.