J. Sklar Mfg. Co., Inc.: FDA clearances and approvals
J. Sklar Mfg. Co., Inc. has 18 FDA 510(k) clearances (first 1977, latest 1984), across 12 product codes in 4 review panels. Median 510(k) review time: 28 days.
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 |
|---|---|---|---|
| HFB | Forceps, Biopsy, Gynecological | 3 | 3 |
| HNF | Scissors, Ophthalmic | 3 | 3 |
| FZT | Cutter, Surgical | 2 | 2 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 | 1 |
| HCF | Instrument, Ligature Passing And Knot Tying | 1 | 1 |
| HCZ | Forceps, Surgical, Gynecological | 1 | 1 |
| HGC | Clamp, Uterine | 1 | 1 |
| HGN | Stethoscope, Fetal | 1 | 1 |
Plus 2 more product codes.
Review panels
- Obstetrics and Gynecology (7)
- General and Plastic Surgery (6)
- Ophthalmic (3)
- Gastroenterology and Urology (2)
Most recent J. Sklar Mfg. Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K843693 | JACOBS HIGH VACUUM SUCTION UNIT 05-2570 | BTA | 1984-10-31 | 42 |
| K842112 | TISCHLER CERVICAL BIOPSY PUNCH FORCEPS | HFB | 1984-07-03 | 35 |
| K842111 | KOGAN ENDOSPECULUM 9-1/2 | HTZ | 1984-06-19 | 21 |
| K822448 | SCISSORS, VARIOUS | FZT | 1982-09-14 | 29 |
| K802458 | KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611 | HFB | 1981-01-12 | 96 |
| K802457 | KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610 | HFB | 1981-01-12 | 96 |
| K801273 | MAGILL CATHETER INTRO. FORCEPS | KOA | 1980-07-28 | 60 |
| K800441 | RUDD-CLINIC HEMORRHOIDAL FORCEPS | KOA | 1980-04-08 | 40 |
| K790577 | HEMORRHOIDAL LIGATOR | HCF | 1979-04-23 | 26 |
| K772230 | CANNULA, PERFUSION, FALLOPIAN TUBE | LKF | 1978-01-03 | 28 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named J. Sklar Mfg. Co., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does J. Sklar Mfg. Co., Inc. have?
J. Sklar Mfg. Co., Inc. has 18 FDA 510(k) clearances (first 1977, latest 1984), across 12 product codes in 4 review panels.
How long does FDA take to clear J. Sklar Mfg. Co., Inc.'s 510(k)s?
The median time from FDA receipt to decision across J. Sklar Mfg. Co., Inc.'s cleared 510(k)s is 28 days.
What devices does J. Sklar Mfg. Co., Inc. make?
Its most frequent FDA product codes are HFB (Forceps, Biopsy, Gynecological, 3); HNF (Scissors, Ophthalmic, 3); FZT (Cutter, Surgical, 2).
Has J. Sklar Mfg. Co., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching J. Sklar Mfg. Co., Inc. Related entities may recall under other names.
Next steps
- See all 18 J. Sklar Mfg. Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code HFB, J. Sklar Mfg. Co., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.