Reznik Instruments: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Reznik Instruments” (first 1981, latest 1981), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 70 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 | 2 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 | 2 |
| FEM | Accessories, Photographic, For Endoscope (Exclude Light Sources) | 1 | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
| HIH | Hysteroscope (And Accessories) | 1 | 1 |
| KOH | Instrument, Manual, General Obstetric-Gynecologic | 1 | 1 |
Review panels
Most recent Reznik Instruments 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K812205 | FORCEP | GEN | 1981-10-26 | 83 |
| K812201 | PHOTOGRAPHIC EQUIPMENT | FEM | 1981-10-19 | 76 |
| K812206 | LAPAROSCOPE | HET | 1981-10-13 | 70 |
| K812204 | UTERINE MANIPULATORS | KOH | 1981-10-13 | 70 |
| K812203 | ELECTROSURGICAL UNIT | GEI | 1981-10-13 | 70 |
| K812199 | TROCAR & TROCAR SLEEVES | HET | 1981-10-13 | 70 |
| K812202 | FIBER OPTIC LIGHT SOURCE | HIH | 1981-09-29 | 56 |
| K812200 | INSUFFLATOR | HIF | 1981-09-29 | 56 |
| K812198 | ACCESSORIES(PROBES, SUCTION TUBES, ETC.) | GEI | 1981-09-11 | 38 |
Recalls
openFDA lists no recalls under a recalling firm named Reznik Instruments.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Reznik Instruments?
FDA lists 9 510(k) clearances under the applicant name “Reznik Instruments” (first 1981, latest 1981), across 7 product codes in 3 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 Reznik Instruments?
The median time from FDA receipt to decision across 510(k)s cleared under the name Reznik Instruments is 70 days.
Which FDA product codes appear under Reznik Instruments?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); HET (Laparoscope, Gynecologic (And Accessories), 2); FEM (Accessories, Photographic, For Endoscope (Exclude Light Sources), 1).
Next steps
- See all 9 Reznik Instruments clearances with predicates and recalls
- Run predicate analysis for product code GEI, Reznik Instruments'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.