510(k) Report

FDA applicant

Sgarlato Laboratories, Inc.

San Jose, CA8 decisions1989–20051 recall

FDA records 8 decisions for Sgarlato Laboratories, Inc. (San Jose, CA) from 1989 to 2005: 8 510(k) clearances. Most are in product codes KWH (Prosthesis, Toe, Constrained, Polymer) and FRN (Pump, Infusion). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 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, orthopedic panel, where it files most

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

FDA decisions per year

No FDA decision for Sgarlato Laboratories, Inc. since 2007.

Recalls per year

1in 2009

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

Class I Class II/III not classified

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

Planning a device like Sgarlato Laboratories, 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

Which product codes does it file in?

  • KWHProsthesis, Toe, Constrained, Polymer2decisions
  • FRNPump, Infusion2decisions
  • JDWPin, Fixation, Threaded1decision
  • MJWProsthesis, Subtalar, Plug, Polymer1decision
  • KQWGoniometer, Nonpowered1decision
  • BXBExerciser, Powered1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K990101Pain Control Infusion PumpSgarlato Laboratories, Inc. · 19992cite it
  • K982931Threaded Fixation PinSgarlato Laboratories, Inc. · 19981cites it
  • K905795Sgarlato Flexible Hinge Toe ImplantSgarlato Laboratories, Inc. · 19911cites it
  • K884739Sgarlato Lesser Toe ImplantSgarlato Laboratories, Inc. · 19891cites it

What has FDA decided for it lately?

  • K043204Sgarlato Labs Painfree Pump and Pain Control Infusion PumpSgarlato Laboratories, Inc. · 2005
  • K990101Pain Control Infusion PumpSgarlato Laboratories, Inc. · 1999
  • K982931Threaded Fixation PinSgarlato Laboratories, Inc. · 1998
  • K926262First MPJ Continuous Passive Motion DeviceSgarlato Laboratories, Inc. · 1994
  • K926237O'brien GoniometerSgarlato Laboratories, Inc. · 1993
  • K922292Lundeen Subtalar Peg ImplantSgarlato Laboratories, Inc. · 1992
  • K905795Sgarlato Flexible Hinge Toe ImplantSgarlato Laboratories, Inc. · 19911 recall
  • K884739Sgarlato Lesser Toe ImplantSgarlato Laboratories, Inc. · 1989

All 8 as Sgarlato Laboratories, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K905795Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number…Mar 1, 2009