510(k) Report

510(k) · Cleared

Cleared

STERRAD 100NX Sterilizer with ALLClearTM Technology

K160903510(k) TraditionalCleared Sep 26, 2016178-day reviewClass II21 CFR 880.6860

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 Sep 26, 2016 as substantially equivalent to K071385 (Advanced Sterilization Products, 2007) and 3 other predicates after a 178-day review. Its family tree reaches back 4 generations to 2005. 4 later devices descend from it.

Decided
Sep 26, 2016
Review
178 days
Class
Class II
Product code
MLR
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K042116 (2005). 9 ancestors in all, the oldest K981625 (1999). 4 later devices descend 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 ancestor2021: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared2026: 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
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant K142454 · STERRAD NX Sterilizer, STERRAD 100NX Sterilizer · Advanced Sterilization Products · 2015 · recalledK092622 · Sterrad 100NX Sterilizer Express Cycle · Advanced Sterilization Products · 2011K071385 · Sterrad 100NX Sterilizer · Advanced Sterilization Products · 2007 · recalledK042116 · Sterrad NX Sterilizer · Advanced Sterilization Products · 2005 · recalled0
  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 deviceK160903 STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products · 2016
  6. Descendant · cites it directly · 3 of its ownK212174 STERRAD 100NX Sterilizer with ALLClear TechnologyAdvanced Sterilization Products, Inc. · 2021
  7. Descendant · 2 generations on · 2 of its ownK234082 STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™…Advanced Sterilization Products · 2024
  8. Descendant · 3 generations on · 1 of its ownK250802 STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)Advanced Sterilization Products, Inc. · 2025
  9. Descendant · 4 generations on · 0 of its ownK252843 STERRAD 100NX Sterilization System with ALLClear Technology (10104)Advanced Sterilization Products, Inc. · 2026

Most influential descendants

Showing 4 of 4 · See all
  • K212174STERRAD 100NX Sterilizer with ALLClear TechnologyAdvanced Sterilization Products, Inc. · 2021 · cites it directly3descendants
  • K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104)…Advanced Sterilization Products · 2024 · 2 generations on2descendants
  • K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)Advanced Sterilization Products, Inc. · 2025 · 3 generations on1descendant
  • K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)Advanced Sterilization Products, Inc. · 2026 · 4 generations on0descendants
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)K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products2016—
+1K212174STERRAD 100NX Sterilizer with ALLClear TechnologyAdvanced Sterilization Products, Inc.2021—
+2K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle…Advanced Sterilization Products2024—
+3K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)Advanced Sterilization Products, Inc.2025—
+4K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)Advanced Sterilization Products, Inc.2026—

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
202110
202410
202510
202610
FIG. 1 — Lineage of K160903, 2005–2026Source: 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? (4)

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
*K071385Sterrad 100NX Sterilizer
Summary page 5
…r Device Class: Class II Product Code: MLR CFR Section: 21 CFR 880.6860 Predicate Device STERRAD 100NX Sterilizer cleared under 510(k) numbers K071385 (November 19, 2007), K092622 (March 4, 2011), K111377 (September 13, 2012), and K142454 (April 3, 2015).…
Advanced Sterilization Products20075
*K092622Sterrad 100NX Sterilizer Express Cycle
Summary page 5
…II Product Code: MLR CFR Section: 21 CFR 880.6860 Predicate Device STERRAD 100NX Sterilizer cleared under 510(k) numbers K071385 (November 19, 2007), K092622 (March 4, 2011), K111377 (September 13, 2012), and K142454 (April 3, 2015).…
Advanced Sterilization Products2011—
*K111377Sterrad (R) 100NX Sterilizer Duo Cycle
Summary page 5
…MLR CFR Section: 21 CFR 880.6860 Predicate Device STERRAD 100NX Sterilizer cleared under 510(k) numbers K071385 (November 19, 2007), K092622 (March 4, 2011), K111377 (September 13, 2012), and K142454 (April 3, 2015).…
Advanced Sterilization Products20121
*K142454STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
Summary page 5
…880.6860 Predicate Device STERRAD 100NX Sterilizer cleared under 510(k) numbers K071385 (November 19, 2007), K092622 (March 4, 2011), K111377 (September 13, 2012), and K142454 (April 3, 2015). i === Page 6…
Advanced Sterilization Products20152

Also cleared against K071385: 3 other devices →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K212174STERRAD 100NX Sterilizer with ALLClear TechnologyAdvanced Sterilization Products, Inc.20213

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

No FDA recall names this device.

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, K212174 (Advanced Sterilization Products, Inc., 2021) has gone furthest, with 3 descendants of its own.
  • 3 other devices also cite its predicate K071385.

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 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…

Read the full statement (413 words)

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.

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.

* 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.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K160903: STERRAD 100NX Sterilizer with ALLClearTM Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160903

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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