Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Spsmedical Supply Corp. · Predicate Candidate Screening

28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

174 daysmedian FDA review time
276 days90th percentile
28clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K122024SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICSpsmedical Supply Corp.2013-11-265030
K130211AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETSSpsmedical Supply Corp.2013-07-051570
K111515SPSMEDICAL SPORVIEW STEAM BISpsmedical Supply Corp.2012-02-012450
K110152SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORSSpsmedical Supply Corp.2011-04-15860
K102363SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-10Spsmedical Supply Corp.2011-01-271600
K090650SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORSSpsmedical Supply Corp.2009-10-092120
K081879SPSMEDICAL SPORVIEW PA CULTURE SETSpsmedical Supply Corp.2008-07-30280
K070595SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATORSpsmedical Supply Corp.2007-05-24830
K063799STEAMPLUS STEAM INTEGRATORSpsmedical Supply Corp.2007-01-05140
K051173SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACKSpsmedical Supply Corp.2005-05-27210
K043135SPSMEDICAL SPORVIEW PA CULTURE SETSpsmedical Supply Corp.2005-01-13620
K041017SPSMEDICAL AIRVIEW BOWIE DICK TEST PACKSpsmedical Supply Corp.2004-06-25660
K041099MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIPSpsmedical Supply Corp.2004-05-06101
K030680SPSMEDICAL GAS PLASMA CHEMICAL INDICATORSpsmedical Supply Corp.2003-05-09650
K023716SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIPSpsmedical Supply Corp.2002-12-05301
K022706SPSMEDICAL SPORVIEW STEAM BI TEST PACKSpsmedical Supply Corp.2002-10-25720
K020409STEAMPLUS STERILIZATION TESTSpsmedical Supply Corp.2002-07-181611
K905425SPORVIEWSpsmedical Supply Corp.1992-03-274792
K890754SPORVIEW CULTURE MEDIASpsmedical Supply Corp.1989-11-172760
K890757C-VAPOR STERILIZATION INDICATOR, CHEMICAL VAPORSpsmedical Supply Corp.1989-08-071740
K890760STRIP, STERILIZATION INDICATOR, E.O. GASSpsmedical Supply Corp.1989-08-071740
K890763LABEL, STERILIZATION INDICATOR; DUAL STEAM/E.O.GASSpsmedical Supply Corp.1989-08-071740
K890765STRIP, STERILIZATION INDICATOR; STEAM OR E.O. GASSpsmedical Supply Corp.1989-08-071740
K890764LABEL, STERILIZATION INDICATOR; RADIATIONSpsmedical Supply Corp.1989-08-071740
K890759STRIP, STERILIZATION INDICATOR; STEAMSpsmedical Supply Corp.1989-08-071741
K890761STRIP, STERILIZATION INDICATOR; DRY HEATSpsmedical Supply Corp.1989-08-071740
K890758DRY HEAT STERILIZATION INDICATOR TAPESpsmedical Supply Corp.1989-08-071740
K890755SEALING TAPE, STERILIZATION INDICATOR; STEAMSpsmedical Supply Corp.1989-08-071740

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda