510(k) · Cleared
Recalled · Class II · 2013Sterrad 100NX Sterilizer
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 Nov 29, 2007 as substantially equivalent to K042116 (Advanced Sterilization Products, 2005) after a 195-day review. Its family tree reaches back 1 generation to 2005. 19 later devices descend from it. It has been recalled 5 times.
- Decided
- Nov 29, 2007
- Review
- 195 days
- Class
- Class II
- Product code
- MLR
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042116 (2005). 19 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK042116 Sterrad NX SterilizerAdvanced Sterilization Products · 2005 · Recalled
- This deviceK071385 Sterrad 100NX SterilizerAdvanced Sterilization Products · 2007
- Descendant · cites it directly · 17 of its ownK111377 Sterrad (R) 100NX Sterilizer Duo CycleAdvanced Sterilization Products · 2012 · Recalled
- Descendant · cites it directly · 10 of its ownK092622 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 · 2 generations on · 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
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K111377Sterrad (R) 100NX Sterilizer Duo CycleAdvanced Sterilization Products · 2012 · cites it directly17descendants
- K092622Sterrad 100NX Sterilizer Express CycleAdvanced Sterilization Products · 2011 · cites it directly10descendants
- K142454STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products · 2015 · cites it directly9descendants
- K141163Sterizone SterilizerTso3, Inc. · 2014 · 2 generations on5descendants
- K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products · 2016 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042116 | Sterrad NX Sterilizer | Advanced Sterilization Products | 2005 | 10 |
| 0 (this device) | K071385 | Sterrad 100NX Sterilizer | Advanced Sterilization Products | 2007 | — |
| +1 | K111377 | Sterrad (R) 100NX Sterilizer Duo Cycle | Advanced Sterilization Products | 2012 | 1 |
| +1 | K092622 | Sterrad 100NX Sterilizer Express Cycle | Advanced Sterilization Products | 2011 | — |
| +1 | K142454 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | Advanced Sterilization Products | 2015 | 2 |
| +2 | K141163 | Sterizone Sterilizer | Tso3, Inc. | 2014 | — |
| +1 | K160903 | STERRAD 100NX Sterilizer with ALLClearTM Technology | Advanced Sterilization Products | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042116 | Sterrad NX SterilizerSummary page 1…Product Classification: Sterilizer, Class IF Proprietary Name: STERRAD® 100NXT4 Sterilizer 2.0 PREDICATE DEVICES STERRAD® NX® Sterilization System [K042116] 3.0 INDICATIONS FOR USE The STERRAD 100NXTM Sterilizer is designed for sterilization of both metal and nonmeta… | 2005 |
What descends from it? (19)
See all 194 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 11, 2013 | Class II | Z-0402-2014 | Labeling design | Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not… |
| Sep 18, 2013 | Class II | Z-0044-2014 | Under Investigation by firm | Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's… |
| Jul 25, 2013 | Class II | Z-2174-2013 | Under Investigation by firm | The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100 NX… |
| Mar 22, 2013 | Class II | Z-1026-2013 | Nonconforming Material/Component | The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal… |
| Feb 25, 2008 | Not classified | Z-1632-2008 | Device Design | Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, "haze," or "smoke." |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MLR devicesMLR Sterilizer, Chemical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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® 100NXTM 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 TM Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.…
Read the full statement (224 words)
The STERRAD® 100NXTM 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 TM 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 100NXTM 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® 100NXTM 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071385 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071385: Sterrad 100NX Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071385
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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