Atlas FDA

3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM

FDA 510(k) clearance K101528 · decided 2010-10-01

Clearance details

K-number
K101528
Device name
3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM
Applicant
3M Company
Decision
Substantially Equivalent
Date received
2010-06-02
Decision date
2010-10-01
Days to decision
121 days
Clearance type
Traditional
Product code
JOJ
Device class
2
Regulation number
880.2800
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
St. Paul, MN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch 3M Company

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
LF Process Indicator Tape for Steam Sterilization (K260181)Intertape Polymer Group2026-02-20
SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) (K251991)Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.2025-12-23
DISINTEK™ PA Test Strips (K251035)Serim Research2025-06-03
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 (K251048)STERIS Corporation2025-05-02
VERIFY STEAM Integrating Indicator (K243876)STERIS Corporation2025-04-25
Green Card Bowie-Dick Test (BD115) (K250172)Steritec Products, Inc. (A Getinge Company)2025-02-20
Type 5 Integrating Indicator for Steam (CSPN-15) (K242860)True Indicating, LLC2025-01-17
Autoclave Indicator Tape; EO Indicator Tape (K241036)Jiangmen New Era External Use Drug Co., Ltd.2024-12-17
Chemical Indicator for enspire CLCSPS (LCC015) (K243475)STERIS Corporation2024-12-04
Getinge Assured MI Steam Migrating Integrator (K242795)Steritec Products Mfg. (A Getinge Group Company)2024-10-15
Kem Medical Lead-free Chemical Indicators for Steam Sterilization (K241836)Kem Medical Products Corporation2024-09-30
CELERITY HP Indicator Tape (PCC077) (K242189)Steris2024-08-20

Recalls involving this device

RecordFirmDate
a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest recall (Z-1794-2022)Mckesson Medical-Surgical Inc. Corporate Office2022-09-26

PMA approvals by this applicant

RecordFirmDate
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011)3M Company1994-11-28
CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010)3M Company1994-05-19
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006)3M Company1992-12-31
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009)3M Company1992-03-13
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008)3M Company1992-01-28
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007)3M Company1990-10-17
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005)3M Company1990-03-08
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004)3M Company1989-11-22