510(k) Report

FDA applicant

Carl Parker Associates, Inc.

Hauppauge, NY7 decisions1987–19970 recalls

FDA records 7 decisions for Carl Parker Associates, Inc. (Hauppauge, NY) from 1987 to 1997: 7 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and LYY (Latex Patient Examination Glove). Its devices cite 3 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 and plastic surgery panel, where it files most

How often FDA has decided Carl Parker Associates, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Carl Parker Associates, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Carl Parker Associates, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Carl Parker Associates, 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 “Carl”

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