Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

FRC · Predicate Candidate Screening

206 FDA 510(k) clearances under this product code; the 50 most recent screened below.

116 daysmedian FDA review time
385 days90th percentile
206clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260766Celerity 5 HP Biological Indicator (LCB052)STERIS Corporation2026-04-08300
K252680Celerity™ 20 HP Biological IndicatorSTERIS Corporation2025-09-24300
K251122Terragene® Bionova® BT20 Biological IndicatorTerragene2025-08-041150
K251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP CSteris2025-06-06280
K250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP CSTERIS Corporation2025-02-06270
K250061Celerity IncubatorSTERIS Corporation2025-02-06270
K2435013M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge3M Company2025-01-28770
K242453Terragene® Bionova® Photon Process Challenge Device with uniTerragene S.A.2024-12-121150
K2425383M™ Attest™ Super Rapid Readout Biological Indicator 1493; 33M Company2024-11-25910
K2419593M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD)3M Company2024-10-181070
K231383Terragene® Bionova® Self-Contained Biological Indicator (BT9Terragene S.A.2024-09-184950
K2417103M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M Company2024-09-12900
K2407173M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ 3M Company2024-06-271040
K2415423M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Ch3M Company2024-06-27270
K2338143M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Ch3M Company2024-03-151060
K233681ConFirm 20 Minute IncubatorSTERIS Corporation2023-12-15290
K231490Celerity 20 HP Biological Indicator; VERIFY V24 Self-ContainSTERIS Corporation2023-08-07760
K223715Celerity IncubatorSTERIS Corporation2023-06-151950
K223717Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge STERIS Corporation2023-06-151850
K223023Terragene Bionava SCBI (BT96), Terragene Bionova Reader IncuPlasmapp Co,., Ltd.2023-05-092220
K221641Terragene® Bionova® Hyper Biological Indicator (BT98), TerraTerragene S.A.2023-02-282670
K213881Celerity IncubatorSTERIS Corporation2022-07-212200
K2117053M Attest Rapid Readout Biological Indicator, 12953M Company2022-06-283900
K213296Anprolene SteriTest RRBIAndersen Sterilizers, Inc.2022-04-121930
K2138093M Attest Super Rapid Steam Biological Indicator, 3M Attest 3M Company2022-04-061210
K220473CELERITY 20 HP Challenge PackSteris2022-03-18280
K212193Terragene Bionova SCBI (BT96), Terragene Bionova Reader IncuPlasmapp Co,., Ltd.2021-10-221000
K203560STERIZONE VP4 Test PackTso3 Inc., Now A Part of Stryker2021-03-241070
K202879EOGas 4 Endo-SteriTest RRBIAndersen Sterilizers, Inc.2021-03-031560
K2102773M Attest Rapid Readout Biological Indicator, 12953M Company2021-03-03300
K202721Celerity 20 Steam Biological Indicator for IUSSSTERIS Corporation2021-01-081130
K200970Self-Contained Biological IndicatorTrue Indicating, LLC2020-12-282590
K2009963M Attest Rapid Readout Biological Indicator3M Company2020-12-112390
K192980EOGas 4 Endo-SteriTestAndersen Sterilizers, Inc.2020-11-123850
K2007663M Attest Steam Chemical Integrator Test Pack3M Company2020-07-02990
K1925503MTM AttestTM Super Rapid Steam Biological Indicator 1592, 33M Company2020-06-052620
K2005363MTM AttestTM Rapid 5 Steam-Plus Test Pack3M Complany2020-06-01900
K200126VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation2020-05-221220
K2000923MTM AttestTM Mini Auto-reader 490M3M2020-04-15900
K1931543M Attest Super Rapid 5 Steam-Plus Challenge Pack3M Company2020-02-07852
K192025STERRAD VELOCITY Biological Indicator/Process Challenge DeviAdvanced Sterilization Products (Asp)2020-01-231780
K192001Sterilucent self-Contained Biological Indicator, SterilucentSterilucent, Inc.2019-10-22880
K191021Terragene Bionova, Terragene Bionova, Terragene Integron, TeTerragene S.A.2019-09-131491
K190297Celerity HP IncubatorSTERIS Corporation2019-05-14920
K183294CELERITY 20 HP Biological Indicator, CELERITY HP Challenge PSTERIS Corporation2019-01-03370
K183300VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 BSteris Corporations2019-01-03370
K182404STERRAD VELOCITY Biological IndicatorAdvanced Sterilization Products (Asp)2018-12-271140
K182931VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-OnSteris Corporations2018-11-20290
K181434SporView Rapid Read Biological Indicator SteamPlus Test PackCrosstex/Spsmedical, A Division of Cantel Medical2018-11-141660
K181686CELERITY 20 Steam Biological IndicatorSTERIS Corporation2018-07-24280

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