510(k) · Cleared
ClearedSTERRAD NX 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 Feb 16, 2017 as substantially equivalent to K042116 (Advanced Sterilization Products, 2005) and 2 other predicates after a 211-day review. Its family tree reaches back 5 generations to 2005.
- Decided
- Feb 16, 2017
- Review
- 211 days
- Class
- Class II
- Product code
- MLR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K042116 (2005). 10 ancestors in all, the oldest K981625 (1999). No later device cites it as a predicate yet.
- Root · 5 generations backK042116 Sterrad NX SterilizerAdvanced Sterilization Products · 2005 · Recalled
- 4 generations backK071385 Sterrad 100NX SterilizerAdvanced Sterilization Products · 2007 · Recalled
- 3 generations backK092622 Sterrad 100NX Sterilizer Express CycleAdvanced Sterilization Products · 2011
- 2 generations backK142454 STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products · 2015 · Recalled
- 1 generation backK151725 STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products · 2016 · Recalled
- This deviceK162007 STERRAD NX SterilizerAdvanced Sterilization Products · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042116 | Sterrad NX Sterilizer | Advanced Sterilization Products | 2005 | 10 |
| −4 | K071385 | Sterrad 100NX Sterilizer | Advanced Sterilization Products | 2007 | 5 |
| −3 | K092622 | Sterrad 100NX Sterilizer Express Cycle | Advanced Sterilization Products | 2011 | — |
| −2 | K142454 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | Advanced Sterilization Products | 2015 | 2 |
| −1 | K151725 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | Advanced Sterilization Products | 2016 | 1 |
| 0 (this device) | K162007 | STERRAD NX Sterilizer | Advanced Sterilization Products | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K042116 | Sterrad NX SterilizerSummary page 5…erilizer Device Class: Class II Product Code: MLR CFR Section: 21 CFR 880.6860 Predicate Device STERRAD NX Sterilizer originally cleared under K042116. Description The STERRAD NX Sterilizer is a self-contained, stand-alone system of hardware and software designed to sterilize m… | 2005 |
| * | K142454 | STERRAD NX Sterilizer, STERRAD 100NX SterilizerSummary page 9…Predicate STERRAD NX Sterilizer Modified Characteristic K042116, K142454 and K151725 STERRAD NX Sterilizer Intended Use Designed for sterilization of both metal and… | 2015 |
| * | K151725 | STERRAD NX Sterilizer, STERRAD 100NX SterilizerSummary page 9…Predicate STERRAD NX Sterilizer Modified Characteristic K042116, K142454 and K151725 STERRAD NX Sterilizer Intended Use Designed for sterilization of both metal and Sam… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 1 company; a new generation was cleared every 2.6 years on median.
- 9 of the 10 ancestors have a recall of any class.
- 4 other devices also cite its predicate K042116.
How does its category compare?
All MLR devicesMLR Sterilizer, Chemical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 NX 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 NX Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. Medical devices…
Read the full statement (281 words)
The STERRAD NX 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 NX 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 NX Sterilizer STANDARD cycle:
Single channel stainless steel lumens with
• An inside diameter of 1 mm or larger and a length of 150 mm or shorter†
• An inside diameter of 2 mm or larger and a length of 400 mm or shorter†
Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD NX Sterilizer ADVANCED cycle:
Single channel stainless steel lumens with
• An inside diameter of 1 mm or larger and a length of 500 mm or shorter†
Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope 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, validation studies were performed using a validation load consisting of one instrument tray weighing 10.7 lbs. The 1 x 850 mm flexible endoscope was validated without any additional load.
†The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.
*Only one flexible endoscope can be processed per sterilization cycle with or without a silicone mat. No additional load.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162007 · printed Nov 3, 2026
Cite this page
510(k) Report. “K162007: STERRAD NX Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K162007
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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