510(k) Report

FDA applicant

Reganes, Inc.

Clearwater, FL2 decisions1985–19882 recalls

FDA records 2 decisions for Reganes, Inc. (Clearwater, FL) from 1985 to 1988: 2 510(k) clearances. Most are in product codes BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)) and CAZ (Anesthesia Conduction Kit). 2 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Reganes, Inc. since 2007.

Recalls per year

2in 2015

2015: 2
2007high 2 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Reganes, 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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Which product codes does it file in?

  • BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)1decision
  • CAZAnesthesia Conduction Kit1decision

What has FDA decided for it lately?

  • K880181Reganes Disposable Epidural Anesthesia TrayReganes, Inc. · 1988
  • K854816Epidural Anesthesia NeedlesReganes, Inc. · 19852 recalls

All 2 as Reganes, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K854816Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch.…May 1, 2015Class II
  • K854816Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch…Mar 30, 2015Class II