510(k) Report

510(k) · Cleared

Cleared

STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)

K250802510(k) TraditionalCleared Apr 14, 202531-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, Inc. · MLR Sterilizer, Chemical

Cleared on Apr 14, 2025 as substantially equivalent to K234082 (Advanced Sterilization Products, 2024) after a 31-day review. Its family tree reaches back 7 generations to 2005. 1 later device descends from it.

Decided
Apr 14, 2025
Review
31 days
Class
Class II
Product code
MLR
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K042116 (2005). 13 ancestors in all, the oldest K981625 (1999). 1 later device descends from it, 1 citing it directly.

  1. Root · 7 generations backK042116 Sterrad NX SterilizerAdvanced Sterilization Products · 2005 · Recalled
  2. 6 generations backK071385 Sterrad 100NX SterilizerAdvanced Sterilization Products · 2007 · Recalled
  3. 5 generations backK092622 Sterrad 100NX Sterilizer Express CycleAdvanced Sterilization Products · 2011
  4. 4 generations backK142454 STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products · 2015 · Recalled
  5. 3 generations backK160903 STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products · 2016
  6. 2 generations backK212174 STERRAD 100NX Sterilizer with ALLClear TechnologyAdvanced Sterilization Products, Inc. · 2021
  7. 1 generation backK234082 STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™…Advanced Sterilization Products · 2024
  8. This deviceK250802 STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)Advanced Sterilization Products, Inc. · 2025
  9. Descendant · cites it directly · 0 of its ownK252843 STERRAD 100NX Sterilization System with ALLClear Technology (10104)Advanced Sterilization Products, Inc. · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)Advanced Sterilization Products, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K042116Sterrad NX SterilizerAdvanced Sterilization Products200510
−6K071385Sterrad 100NX SterilizerAdvanced Sterilization Products20075
−5K092622Sterrad 100NX Sterilizer Express CycleAdvanced Sterilization Products2011—
−4K142454STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products20152
−3K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products2016—
−2K212174STERRAD 100NX Sterilizer with ALLClear TechnologyAdvanced Sterilization Products, Inc.2021—
−1K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle…Advanced Sterilization Products2024—
0 (this device)K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)Advanced Sterilization Products, Inc.2025—
+1K252843STERRAD 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
200210
200320
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K250802, 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 K252843 STERRAD 100NX Sterilization System with…score 13.3 · 8 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
*K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104)…
Summary page 6
…MLR Device Class: Class II CFR Section: 21 CFR 880.6860 Predicate Devices STERRAD 100NX Sterilizer with ALLClear Technology K234082 cleared July 5, 2024. Device Description The STERRAD 100NX Sterilization System with ALLClear Technology is a self-contained st…
Advanced Sterilization Products2024—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)Advanced Sterilization Products, Inc.20260

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 20 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
  • 8 of the 13 ancestors have a recall of any class.
  • Of its descendants, K252843 (Advanced Sterilization Products, Inc., 2026) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MLR devices

MLR Sterilizer, Chemical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 with ALLClear Technology 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…

Read the full statement (613 words)

The STERRAD 100NX Sterilizer with ALLClear Technology 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. A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle.

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 1065 mm or shorter. A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load.

Note: With the exception of the 1 x 1065 mm flexible endoscopes, the validation studies were performed using a validation load consisting of two instrument trays each weighing 10.7 Ibs. The 1 x 1065 mm flexible endoscopes were validated without any additional load.

The STERRAD 100NX EXPRESS Cycle is 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 Ibs placed on the bottom shelf.

The STERRAD 100NX DUO Cycle is 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 1: 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 Ibs.

* One Dual channel flexible endoscope with two polyethylene and Teflon (polytetrafluoroethylene) lumens that each have an inside diameter of 1 mm or larger and a length of 885 mm or shorter.

Note 2: The validation studies for DUO Cycle was performed using a validation load consisting of 1 dual channel endoscope with >1 mm diameter x <885 mm long and >2.2 mm diameter x <835 mm long PTFE/PE lumens, and 1 dual channel endescope with >1 mm diameter x <670 mm long and >2.2 mm diameter x <845 mm long PTFE/PE lumens

The STERRAD 100NX Sterilizer ULTRA GI Cycle is designed for sterilization of the following:

» Medical devices, including multi-channel endoscopes (including duodenoscopes), with no more than 4 channels, with lumen dimensions of >1mm x <1500mm in length, and >2mm x <1630mm in length.

* One flexible endoscope per tray, and no more than two flexible endoscopes per cycle

Notel: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 Ibs), one endoscope per shelf.

Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable.

Check STERRAD User Guide “STERRAD Sterilizer Cycle Selection table” for ULTRA GI compatible duodenoscopes.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K250802: STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250802

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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