Atlas FDA

STERRAD NX STERILIZER

FDA 510(k) clearance K042116 · decided 2005-04-22

Clearance details

K-number
K042116
Device name
STERRAD NX STERILIZER
Applicant
Advanced Sterilization Products
Decision
Substantially Equivalent
Date received
2004-08-05
Decision date
2005-04-22
Days to decision
260 days
Clearance type
Traditional
Product code
MLR
Device class
2
Regulation number
880.6860
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Irvin, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Advanced Sterilization Products

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
STERRAD 100NX Sterilization System with ALLClear Technology (10104) (K252843)Advanced Sterilization Products, Inc.2026-04-15
STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) (K250802)Advanced Sterilization Products, Inc.2025-04-14
LOWTEM Crystal 120 (K231893)Lowtem Co., Ltd.2024-09-18
STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) (K234082)Advanced Sterilization Products2024-07-05
SteroScope® Sterilization Technology System (K233762)Ideate Medical, Inc.2024-06-27
V-PRO maX 2 Low Temperature Sterilization System (K233065)Steris2023-10-20
V-PRO maX 2 Low Temperature Sterilization System (K223476)STERIS Corporation2023-08-07
STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (K231169)Plasmapp Co,., Ltd.2023-05-25
STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette (K223015)Plasmapp Co,., Ltd.2023-05-09
STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (K220345)Plasmapp Co,., Ltd.2023-04-14
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System (K222093)Steris2022-09-09
STERRAD NX with ALLClear Technology (K220404)Advanced Sterilization Products, Inc.2022-05-16

Recalls involving this device

RecordFirmDate
STERRAD NX Sterilization System, Product Code: 10033, 10033-002 recall (Z-1197-2017)Advanced Sterilization Products2017-02-14
STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization Sys recall (Z-0845-2015)Advanced Sterilization Products2014-12-22
STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System i recall (Z-0744-2014)Advanced Sterilization Products2014-01-14
STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature gen recall (Z-0403-2014)Advanced Sterilization Products2013-11-26
STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations system recall (Z-2338-2012)Advanced Sterilization Products2012-09-07
STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer Product Code 10133. The STER recall (Z-0468-2012)Advanced Sterilization Products2012-01-11
STERRAD NX Sterilization System Product Code 10033 The STERRAD Sterilization System is a l recall (Z-1420-2009)Advanced Sterilization Products2009-06-15
STERRAD NX Sterilizer, Product Code 10033 Low temperature sterilizers that use hydrogen pe recall (Z-0484-2009)Advanced Sterilization Products2008-12-02
STERRAD NX Sterilizer, Product Code 10033 Used to sterilize heat and moisture sensitive re recall (Z-1631-2008)Advanced Sterilization Products2008-08-08
STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for U recall (Z-0844-2008)Advanced Sterilization Products2008-02-07