510(k) Report

FDA applicant

Shippert Medical Technologies Corp.

Englewood, CO13 decisions1995–20108 recalls

FDA records 13 decisions for Shippert Medical Technologies Corp. (Englewood, CO) from 1995 to 2010: 13 510(k) clearances. Most are in product codes EMX (Balloon, Epistaxis) and MUU (System, Suction, Lipoplasty). Its devices cite 12 predicates, 4 of them its own earlier devices. 8 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, ear, nose and throat panel, where it files most

How often FDA has decided Shippert Medical Technologies Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2009: 22010: 1
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

7in 2018

2017: 12018: 7
2007high 7 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Shippert Medical Technologies Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shippert Medical Technologies 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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