510(k) Report

FDA applicant

J. Sklar Mfg. Co., Inc.

Mchenry, IL18 decisions1977–19845 recalls

FDA records 18 decisions for J. Sklar Mfg. Co., Inc. (Mchenry, IL) from 1977 to 1984: 18 510(k) clearances. Most are in product codes HFB (Forceps, Biopsy, Gynecological) and HNF (Scissors, Ophthalmic). 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided J. Sklar Mfg. Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for J. Sklar Mfg. Co., Inc. since 2007.

Recalls per year

5in 2024

2024: 5
2007high 5 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — J. Sklar Mfg. Co., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like J. Sklar Mfg. Co., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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