510(k) · Cleared
Recalled · Class II · 2014Sterrad (R) 100NX Sterilizer Duo 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 Sep 13, 2012 as substantially equivalent to K071385 (Advanced Sterilization Products, 2007) and 2 other predicates after a 486-day review. Its family tree reaches back 2 generations to 1999. 17 later devices descend from it. It has been recalled once.
- Decided
- Sep 13, 2012
- Review
- 486 days
- Class
- Class II
- Product code
- MLR
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K981625 (1999). 5 ancestors in all. 17 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK981625 Sterrad 50 SterilizerAdvanced Sterilization Products · 1999 · Recalled
- 1 generation backK023290 Sterrad 50 & Sterrad 100S SterilizersAdvanced Sterilization Products · 2003 · Recalled
- This deviceK111377 Sterrad (R) 100NX Sterilizer Duo CycleAdvanced Sterilization Products · 2012
- Descendant · cites it directly · 9 of its ownK142454 STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products · 2015 · Recalled
- Descendant · cites it directly · 5 of its ownK141163 Sterizone SterilizerTso3, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK160903 STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products · 2016
- Descendant · 2 generations on · 4 of its ownK153392 STERIZONE VP4 SterilizerTs03, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK212174 STERRAD 100NX Sterilizer with ALLClear TechnologyAdvanced Sterilization Products, Inc. · 2021
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K142454STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products · 2015 · cites it directly9descendants
- K141163Sterizone SterilizerTso3, Inc. · 2014 · cites it directly5descendants
- K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products · 2016 · cites it directly4descendants
- K153392STERIZONE VP4 SterilizerTs03, Inc. · 2016 · 2 generations on4descendants
- K212174STERRAD 100NX Sterilizer with ALLClear TechnologyAdvanced Sterilization Products, Inc. · 2021 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981625 | Sterrad 50 Sterilizer | Advanced Sterilization Products | 1999 | 5 |
| −1 | K023290 | Sterrad 50 & Sterrad 100S Sterilizers | Advanced Sterilization Products | 2003 | 9 |
| 0 (this device) | K111377 | Sterrad (R) 100NX Sterilizer Duo Cycle | Advanced Sterilization Products | 2012 | — |
| +1 | K142454 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | Advanced Sterilization Products | 2015 | 2 |
| +1 | K141163 | Sterizone Sterilizer | Tso3, Inc. | 2014 | — |
| +1 | K160903 | STERRAD 100NX Sterilizer with ALLClearTM Technology | Advanced Sterilization Products | 2016 | — |
| +2 | K153392 | STERIZONE VP4 Sterilizer | Ts03, Inc. | 2016 | — |
| +2 | K212174 | STERRAD 100NX Sterilizer with ALLClear Technology | Advanced Sterilization Products, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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? (3)
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…fication Number: 21 CFR 880.6860 Proprietary Name: STERRAD® I100NX® Sterilizer with DUO Cycle 2 PREDICATE DEVICES STERRAD® 100NXO Sterilization System [K071 385] STERRAD®o 1005 Sterilization System [K991999, K023290] 3 INDICATIONS FOR USE The STERRAD® 100NX® Sterilizer is desi… | 2007 |
| * | K991999 | Sterrad 100S SterilizerSummary page 1…e: STERRAD® I100NX® Sterilizer with DUO Cycle 2 PREDICATE DEVICES STERRAD® 100NXO Sterilization System [K071 385] STERRAD®o 1005 Sterilization System [K991999, K023290] 3 INDICATIONS FOR USE The STERRAD® 100NX® Sterilizer is designed for sterilization of both metal and nonmetal… | 2000 |
| * | K023290 | Sterrad 50 & Sterrad 100S SterilizersSummary page 1…STERRAD® I100NX® Sterilizer with DUO Cycle 2 PREDICATE DEVICES STERRAD® 100NXO Sterilization System [K071 385] STERRAD®o 1005 Sterilization System [K991999, K023290] 3 INDICATIONS FOR USE The STERRAD® 100NX® Sterilizer is designed for sterilization of both metal and nonmetal medic… | 2003 |
What descends from it? (17)
See all 174 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2014 | Class II | Z-0846-2015 | Nonconforming Material/Component | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 9.4 years on median.
- 5 of the 5 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. 2012, 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 safely sterilize medical instruments and materials without leaving toxic residue. The STERRAD® 100NX® Sterilizer can sterilize instruments which have diffusion-restricted spaces…
Read the full statement (411 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.
*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 10.1 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.
https://510kreport.com/device/K111377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111377: Sterrad (R) 100NX Sterilizer Duo Cycle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111377
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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