510(k) Report

FDA applicant

Pcca, Inc.

Houston, TX2 decisions2021–20260 recalls

FDA records 2 decisions for Pcca, Inc. (Houston, TX) from 2021 to 2026: 2 510(k) clearances. Most are in product codes OLR (Oral Wound Dressing) and NUC (Lubricant, Personal). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “PCCA, Inc.”.

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 Pcca, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 12026 (partial year): 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Pcca, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report