Microline Pentax, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Microline Pentax, Inc.” (first 1988, latest 2002), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 66 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 7 | 7 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| HNF | Scissors, Ophthalmic | 1 | 1 |
| HNR | Forceps, Ophthalmic | 1 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
Review panels
Most recent Microline Pentax, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013695 | MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10 | GCJ | 2002-01-08 | 62 |
| K982984 | ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS | GEI | 1998-10-21 | 56 |
| K981389 | DISPOSABLE RE-NEW FORCEPS | GEI | 1998-05-29 | 43 |
| K981188 | ELECTROSURGICAL CAUTERY PROBES | GEI | 1998-05-20 | 48 |
| K980758 | 3 MM SELEC-TIP LAPAROSCOPIC SCISSORS | GEI | 1998-03-27 | 28 |
| K974066 | RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS | GEI | 1998-01-22 | 87 |
| K970826 | SELECTA-TIP LAPAROSCOPIC SCISSORS | GEI | 1997-03-28 | 22 |
| K962119 | RE-NEW LAPAROSCOPIC INSTRUMENTS | GEI | 1996-08-09 | 70 |
| K932648 | QUICK SWITCH LAPAROSCOPIC INSTRUMENTS | GCJ | 1993-10-12 | 132 |
| K897093 | INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. | HNF | 1990-04-04 | 105 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Microline Pentax, 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.
- Microline Scientific (14 510(k)s)
- Microline Surgical, Inc. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Microline Pentax, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Microline Pentax, Inc.” (first 1988, latest 2002), 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 Microline Pentax, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microline Pentax, Inc. is 66 days.
Which FDA product codes appear under Microline Pentax, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 7); GCJ (Laparoscope, General & Plastic Surgery, 2); HNF (Scissors, Ophthalmic, 1).
Next steps
- See all 12 Microline Pentax, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Microline Pentax, 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.