510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer

K151725510(k) TraditionalCleared Jan 13, 2016201-day reviewClass II21 CFR 880.6860Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Advanced Sterilization Products · MLR Sterilizer, Chemical

Cleared on Jan 13, 2016 as substantially equivalent to K142454 (Advanced Sterilization Products, 2015) after a 201-day review. Its family tree reaches back 4 generations to 2005. 1 later device descends from it. It has been recalled once.

Decided
Jan 13, 2016
Review
201 days
Class
Class II
Product code
MLR
Recalls
1
Predicates
1

Its longest line of descent runs back 4 generations to K042116 (2005). 9 ancestors in all, the oldest K981625 (1999). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2003: 2 other ancestors2000: 1 other ancestor1999: 1 other ancestor2017: 1 descendant clearedK042116 · Sterrad NX Sterilizer · Advanced Sterilization Products · 2005 · recalledK071385 · Sterrad 100NX Sterilizer · Advanced Sterilization Products · 2007 · recalledK092622 · Sterrad 100NX Sterilizer Express Cycle · Advanced Sterilization Products · 2011K142454 · STERRAD NX Sterilizer, STERRAD 100NX Sterilizer · Advanced Sterilization Products · 2015 · recalled1995200020052010201520202025
  1. Root · 4 generations backK042116 Sterrad NX SterilizerAdvanced Sterilization Products · 2005 · Recalled
  2. 3 generations backK071385 Sterrad 100NX SterilizerAdvanced Sterilization Products · 2007 · Recalled
  3. 2 generations backK092622 Sterrad 100NX Sterilizer Express CycleAdvanced Sterilization Products · 2011
  4. 1 generation backK142454 STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products · 2015 · Recalled
  5. This deviceK151725 STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products · 2016
  6. Descendant · cites it directly · 0 of its ownK162007 STERRAD NX SterilizerAdvanced Sterilization Products · 2017

Most influential descendants

Showing 1 of 1 · See all
  • K162007STERRAD NX SterilizerAdvanced Sterilization Products · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K042116Sterrad NX SterilizerAdvanced Sterilization Products200510
−3K071385Sterrad 100NX SterilizerAdvanced Sterilization Products20075
−2K092622Sterrad 100NX Sterilizer Express CycleAdvanced Sterilization Products2011—
−1K142454STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products20152
0 (this device)K151725STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products2016—
+1K162007STERRAD NX SterilizerAdvanced Sterilization Products2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200320
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
FIG. 1 — Lineage of K151725, 2005–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MLR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MLR device

  1. #1 K250802 STERRAD® 100NX Sterilizer with ALLClear™…score 14.0 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K142454STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
Summary page 6
…ame: Ethylene Oxide Gas Sterilizer (21 CFR 880.6860) Regulatory Class: II Product Code: MLR III. PREDICATE DEVICE STERRAD NX Sterilizer and STERRAD 100NX Sterilizer, K142454 The subject and predicate devices are manufactured by Advanced Sterilization Products. IV. DEVICE DESCRIPTION STERRAD NX Ste…
Advanced Sterilization Products20152

Also cleared against K142454: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K162007STERRAD NX SterilizerAdvanced Sterilization Products20170

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 9, 2017Class IIZ-1197-2017Software designAdvanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 3.3 years on median.
  • 8 of the 9 ancestors have a recall of any class.
  • Of its descendants, K162007 (Advanced Sterilization Products, 2017) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K142454.

How does its category compare?

All MLR devices

MLR Sterilizer, Chemical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · MLR

1in 2025

2007: 22009: 12011: 62012: 22013: 12014: 22015: 12016: 42017: 22018: 22019: 42021: 22022: 22023: 52024: 32025: 12026 (partial year): 1
2007high 6 (2011) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MLR

216in 2024

2011: 214 days median2016: 183 days median2019: 90 days median2023: 222 days median2024: 216 days median
2007high 222 (2023) · low 90 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MLR

1in 2017

2007: 52008: 82009: 22010: 12011: 22012: 32013: 92014: 32017: 1
2007high 9 (2013) · low 0 (2015)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MLR

46in 2025

2007: 2722008: 5362009: 4332010: 2112011: 342012: 1012013: 5412014: 3992015: 4122016: 2862017: 2792018: 2892019: 2222020: 1742021: 2022022: 1882023: 1402024: 442025: 46
2007high 541 (2013) · low 34 (2011)2025

MAUDE reports naming product code MLR, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—5272
20080—8536
20091—2433
20100—1211
20116214234
20122—3101
20131—9541
20142—3399
20151—0412
201641830286
20172—1279
20182—0289
20194900222
20200—0174
20212—0202
20222—0188
202352220140
20243216044
20251—046
20261—0—

What is it indicated for?

The STERRAD® NX® Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization. The STERRAD NX Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. Medical devices…

Read the full statement (693 words)

The STERRAD® NX® Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization. The STERRAD NX Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.

Medical devices with the following materials and dimensions can be processed in the STERRAD NX Sterilizer Standard cycle:

Single channel stainless steel lumens with

• An inside diameter of 1 mm or larger and a length of 150 mm or shorter†

• An inside diameter of 2 mm or larger and a length of 400 mm or shorter†

Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD NX Sterilizer Advanced cycle:

Single channel stainless steel lumens with

• An inside diameter of 1 mm or larger and a length of 500 mm or shorter†

Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope with

• An inside diameter of 1 mm or larger and length of 850 mm or shorter*

†The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.

*Only one flexible endoscope can be processed per sterilization cycle with or without a silicone mat. No additional load.

Note: With the exception of the 1 x 850 mm flexible endoscopes, the validation studies were performed using a validation load consisting of one instrument tray weighing 10.7 lbs. The 1 x 850 mm flexible endoscope was validated without any additional load.

The STERRAD® 100NX® Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to safely sterilize medical instruments and materials without leaving toxic residue.

The STERRAD 100NX Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.

Medical devices with the following materials and dimensions can be processed in the STERRAD 100NX Sterilizer Standard cycle:

• Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter*

Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD 100NX Sterilizer Flex Scope cycle:

• Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and length of 850 mm or shorter**

Note: With the exception of the 1 x 850 mm flexible endoscopes, the validation studies were performed using a validation load consisting of two instrument trays each weighing 10.7 lbs. The 1 x 850 mm flexible endoscopes were validated without any additional load.

*A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle.

**A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load.

The STERRAD 100NX EXPRESS Cycle is an additional optional cycle designed for surface sterilization of both metal and nonmetal medical devices at low temperatures.

• It can sterilize instrument surfaces and instruments having diffusion-restricted spaces, such as the hinged portion of forceps and scissors

• It can sterilize rigid and semi-rigid endoscopes without lumens

Note: The validation studies for EXPRESS Cycle were performed using a validation load consisting of a single instrument tray weighing 10.7 lbs placed on the bottom shelf.

The STERRAD 100NX DUO Cycle is an additional optional cycle designed for sterilization of medical devices including most flexible endoscopes, with the following materials and dimensions:

• Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and a length of 875 mm or shorter

• Accessory devices that are normally connected to a flexible endoscope during use

• Flexible endoscopes without lumens

Note: The validation studies for DUO Cycle were performed using a validation load consisting of two flexible endoscopes with their accessory devices weighing a total of 13.2 lbs.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K151725: STERRAD NX Sterilizer, STERRAD 100NX Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151725

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026