510(k) · Cleared
ClearedSterrad 100NX Sterilizer Express Cycle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Sterilization Products · MLR Sterilizer, Chemical
Cleared on Mar 4, 2011 as substantially equivalent to K071385 (Advanced Sterilization Products, 2007) and 1 other predicate after a 555-day review. Its family tree reaches back 2 generations to 2005. 10 later devices descend from it.
- Decided
- Mar 4, 2011
- Review
- 555 days
- Class
- Class II
- Product code
- MLR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K042116 (2005). 3 ancestors in all, the oldest K030429 (2003). 10 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK042116 Sterrad NX SterilizerAdvanced Sterilization Products · 2005 · Recalled
- 1 generation backK071385 Sterrad 100NX SterilizerAdvanced Sterilization Products · 2007 · Recalled
- This deviceK092622 Sterrad 100NX Sterilizer Express CycleAdvanced Sterilization Products · 2011
- Descendant · cites it directly · 9 of its ownK142454 STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products · 2015 · Recalled
- Descendant · cites it directly · 4 of its ownK160903 STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products · 2016
- Descendant · 2 generations on · 3 of its ownK212174 STERRAD 100NX Sterilizer with ALLClear TechnologyAdvanced Sterilization Products, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK234082 STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™…Advanced Sterilization Products · 2024
- Descendant · 4 generations on · 1 of its ownK250802 STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)Advanced Sterilization Products, Inc. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K142454STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products · 2015 · cites it directly9descendants
- K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products · 2016 · cites it directly4descendants
- K212174STERRAD 100NX Sterilizer with ALLClear TechnologyAdvanced Sterilization Products, Inc. · 2021 · 2 generations on3descendants
- K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104)…Advanced Sterilization Products · 2024 · 3 generations on2descendants
- K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)Advanced Sterilization Products, Inc. · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042116 | Sterrad NX Sterilizer | Advanced Sterilization Products | 2005 | 10 |
| −1 | K071385 | Sterrad 100NX Sterilizer | Advanced Sterilization Products | 2007 | 5 |
| 0 (this device) | K092622 | Sterrad 100NX Sterilizer Express Cycle | Advanced Sterilization Products | 2011 | — |
| +1 | K142454 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | Advanced Sterilization Products | 2015 | 2 |
| +1 | K160903 | STERRAD 100NX Sterilizer with ALLClearTM Technology | Advanced Sterilization Products | 2016 | — |
| +2 | K212174 | STERRAD 100NX Sterilizer with ALLClear Technology | Advanced Sterilization Products, Inc. | 2021 | — |
| +3 | K234082 | STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle… | Advanced Sterilization Products | 2024 | — |
| +4 | K250802 | STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) | Advanced Sterilization Products, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 K250802 STERRAD® 100NX Sterilizer with ALLClear™…score 14.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071385 | Sterrad 100NX SterilizerSummary page 1…on: Sterilizer, Class 11 Proprietary Name: STERRAD" I00NXTrM Sterilizer with EXPRESS Cycle 2.0 PREDICATE DEVICES STERRADO 100NXTM Sterilization System [K071385] STERRAD® 200 Sterilization System [K030429] 3.0 INDICATIONS FOR USE The STERRADe IOONXTM Sterilizer is designe… | 2007 |
| * | K030429 | Sterrad 200 SterilizerSummary page 1…TERRAD" I00NXTrM Sterilizer with EXPRESS Cycle 2.0 PREDICATE DEVICES STERRADO 100NXTM Sterilization System [K071385] STERRAD® 200 Sterilization System [K030429] 3.0 INDICATIONS FOR USE The STERRADe IOONXTM Sterilizer is designed for sterilization of both metal and nonmet… | 2003 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 1 company; a new generation was cleared every 3.3 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K142454 (Advanced Sterilization Products, 2015) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K071385.
How does its category compare?
All MLR devicesMLR Sterilizer, Chemical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MLR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLR
216in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MLR
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLR
46in 2025
MAUDE reports naming product code MLR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 5 | 272 |
| 2008 | 0 | — | 8 | 536 |
| 2009 | 1 | — | 2 | 433 |
| 2010 | 0 | — | 1 | 211 |
| 2011 | 6 | 214 | 2 | 34 |
| 2012 | 2 | — | 3 | 101 |
| 2013 | 1 | — | 9 | 541 |
| 2014 | 2 | — | 3 | 399 |
| 2015 | 1 | — | 0 | 412 |
| 2016 | 4 | 183 | 0 | 286 |
| 2017 | 2 | — | 1 | 279 |
| 2018 | 2 | — | 0 | 289 |
| 2019 | 4 | 90 | 0 | 222 |
| 2020 | 0 | — | 0 | 174 |
| 2021 | 2 | — | 0 | 202 |
| 2022 | 2 | — | 0 | 188 |
| 2023 | 5 | 222 | 0 | 140 |
| 2024 | 3 | 216 | 0 | 44 |
| 2025 | 1 | — | 0 | 46 |
| 2026 | 1 | — | 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 affect sterilization. The STERRAD® 100NX™ Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. Medical…
Read the full statement (305 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 affect sterilization.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092622 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092622: Sterrad 100NX Sterilizer Express Cycle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092622
Report an extraction error
Are you the manufacturer?
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