510(k) Report

FDA applicant

Propper Manufacturing Co., Inc.

Long Island, NY7 decisions2014–20250 recalls

FDA records 7 decisions for Propper Manufacturing Co., Inc. (Long Island, NY) from 2014 to 2025: 7 510(k) clearances. Most are in product codes JOJ (Indicator, Physical/Chemical Sterilization…) and HLI (Ophthalmoscope, Ac-Powered). Since 2016 its 510(k)s took a median of 115 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Propper Manufacturing Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2014: 12021: 22022: 22024: 12025: 1
2014high 2 (2021) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Propper Manufacturing Co., Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Propper Manufacturing 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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Other applicant names beginning “Propper”

FDA records each applicant name separately; these may or may not be the same firm.