510(k) Report

FDA applicant

Nephron Pharmaceuticals Corp.

Orlando, FL3 decisions2012–20232 recalls

FDA records 3 decisions for Nephron Pharmaceuticals Corp. (Orlando, FL) from 2012 to 2023: 3 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and LZA (Polymer Patient Examination Glove). Its devices cite 6 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Nephron Pharmaceuticals Corporation”.

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

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Nephron Pharmaceuticals Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2012: 22023: 1
2012high 2 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

2in 2015

2015: 2
2012high 2 (2015) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Nephron Pharmaceuticals Corp. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nephron Pharmaceuticals Corp.’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 “Nephron”

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