Scieran Technologies, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Scieran Technologies, Inc.” (first 1996, latest 1998), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 104 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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 2 | 2 |
| FCT | Headlight, Fiberoptic Focusing | 1 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
| MRH | Pump, Infusion, Ophthalmic | 1 | 1 |
Review panels
- Ophthalmic (5)
Most recent Scieran Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974253 | CPD COMMANDER | MRH | 1998-02-25 | 104 |
| K980085 | PHACO COMMANDER | HQC | 1998-02-24 | 46 |
| K973749 | FRAG COMMANDER | HQC | 1997-12-08 | 68 |
| K961738 | VIT COMMANDER SYSTEM | HQE | 1996-11-25 | 206 |
| K960767 | LIGHT COMMANDER | FCT | 1996-08-26 | 182 |
Recalls
openFDA lists no recalls under a recalling firm named Scieran Technologies, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Scieran Technologies, Inc. (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 Scieran Technologies, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Scieran Technologies, Inc.” (first 1996, latest 1998), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Scieran Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scieran Technologies, Inc. is 104 days.
Which FDA product codes appear under Scieran Technologies, Inc.?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 2); FCT (Headlight, Fiberoptic Focusing, 1); HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 1).
Next steps
- See all 5 Scieran Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQC, Scieran Technologies, 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.