510(k) Report

FDA applicant

Spsmedical Supply Corp.

Rush, NY28 decisions1989–20134 recalls

FDA records 28 decisions for Spsmedical Supply Corp. (Rush, NY) from 1989 to 2013: 28 510(k) clearances. Most are in product codes JOJ (Indicator, Physical/Chemical Sterilization…) and FRC (Indicator, Biological Sterilization Process). Its devices cite 19 predicates, 12 of them its own earlier devices. 4 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, general hospital panel, where it files most

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

FDA decisions per year

2in 2013

2007: 22008: 12009: 12011: 22012: 12013: 2
2007high 2 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2024

2021: 12022: 22024: 1
2007high 2 (2022) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Spsmedical Supply 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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Which product codes does it file in?

  • JOJIndicator, Physical/Chemical Sterilization Process17decisions
  • FRCIndicator, Biological Sterilization Process9decisions
  • MRBIndicator, Biological, Liquid Chemical Sterilization Process2decisions

Whose devices does it build on?

Its devices cite 19 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 12 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.

  • K905425SporviewSpsmedical Supply Corp. · 19924cite it
  • K030680Spsmedical Gas Plasma Chemical IndicatorSpsmedical Supply Corp. · 20032cite it
  • K110152Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsSpsmedical Supply Corp. · 20112cite it
  • K070595Sporview Steam Self-Contained Biological IndicatorSpsmedical Supply Corp. · 20072cite it
  • K023716Spsmedical Sporview Bacterial Spore StripSpsmedical Supply Corp. · 20021cites it
  • K041017Spsmedical Airview Bowie Dick Test PackSpsmedical Supply Corp. · 20041cites it

What has FDA decided for it lately?

  • K122024Spsmedical Sporview 10 Steam Self Contained Biological IndicatorSpsmedical Supply Corp. · 2013
  • K130211Airview Bowie Dick; Test Pack, Indicator SheetsSpsmedical Supply Corp. · 2013
  • K111515Spsmedical Sporview Steam BISpsmedical Supply Corp. · 2012
  • K110152Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsSpsmedical Supply Corp. · 2011
  • K102363Spsmedical Emplus 270 F Steam Emulator Model Emp-104, Emp-1004Spsmedical Supply Corp. · 2011
  • K090650Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsSpsmedical Supply Corp. · 2009
  • K081879Spsmedical Sporview PA Culture SetSpsmedical Supply Corp. · 2008
  • K070595Sporview Steam Self-Contained Biological IndicatorSpsmedical Supply Corp. · 2007

All 28 as Spsmedical Supply Corp. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K041099Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600.…Dec 11, 2024Class II
  • K905425a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas /…May 25, 2022Class III
  • K890759a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator…May 25, 2022Class III
  • K890761YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF…Dec 29, 2021Class II

Other applicant names beginning “Spsmedical”

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

Spsmedical Supply Corp. A Division of Cantel Medical 1