510(k) · Cleared
Recalled · Class II · 2017Sterrad 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 Apr 22, 2005 after a 260-day review. The FDA summary names its predicate without a number. 36 later devices descend from it. It has been recalled 10 times.
- Decided
- Apr 22, 2005
- Review
- 260 days
- Class
- Class II
- Product code
- MLR
- Recalls
- 10
- Predicates
- 0
36 later devices descend from it, 5 citing it directly.
- This deviceK042116 Sterrad NX SterilizerAdvanced Sterilization Products · 2005
- Descendant · cites it directly · 21 of its ownK102330 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- Descendant · cites it directly · 19 of its ownK071385 Sterrad 100NX SterilizerAdvanced Sterilization Products · 2007 · Recalled
- Descendant · 2 generations on · 18 of its ownK112760 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- Descendant · 2 generations on · 17 of its ownK111377 Sterrad (R) 100NX Sterilizer Duo CycleAdvanced Sterilization Products · 2012 · Recalled
- Descendant · 2 generations on · 17 of its ownK120632 Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization SystemSTERIS Corporation · 2012
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K102330Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011 · cites it directly21descendants
- K071385Sterrad 100NX SterilizerAdvanced Sterilization Products · 2007 · cites it directly19descendants
- K112760Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011 · 2 generations on18descendants
- K111377Sterrad (R) 100NX Sterilizer Duo CycleAdvanced Sterilization Products · 2012 · 2 generations on17descendants
- K120632Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization SystemSTERIS Corporation · 2012 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042116 | Sterrad NX Sterilizer | Advanced Sterilization Products | 2005 | — |
| +1 | K102330 | Amsco V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2011 | — |
| +1 | K071385 | Sterrad 100NX Sterilizer | Advanced Sterilization Products | 2007 | 5 |
| +2 | K112760 | Amsco V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2011 | — |
| +2 | K111377 | Sterrad (R) 100NX Sterilizer Duo Cycle | Advanced Sterilization Products | 2012 | 1 |
| +2 | K120632 | Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization System | STERIS Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 6 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2024 | 3 | 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 |
|---|---|---|---|
| * | — | STERRAD® 50 Sterilization System Named without a submission number | |
| * | — | STERRAD® 100S Sterilization System Named without a submission number | |
| * | — | STERRAD® 200 Sterilization System Named without a submission number |
What descends from it? (36)
See all 365 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 |
|---|---|---|---|---|
| Jan 9, 2017 | Class II | Z-1197-2017 | Software design | Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration. |
| Nov 4, 2014 | Class II | Z-0845-2015 | 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. |
| Dec 16, 2013 | Class II | Z-0744-2014 | Under Investigation by firm | Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems. |
| Nov 11, 2013 | Class II | Z-0403-2014 | 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… |
| Jun 19, 2012 | Class III | Z-2338-2012 | Error in labeling | Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and… |
| Mar 9, 2009 | Not classified | Z-1420-2009 | Component design/selection | ASP has identified a secondary, lower-occurring cause of oil mist within certain STERRAD NX Systems and STERRAD 50 Systems due to potentially defective oil fill plugs. |
| Dec 10, 2008 | Not classified | Z-0468-2012 | Error in labeling | Advanced Sterilization Products (ASP) has discovered a defect in the barcode labeling of the STERRAD NX System Cassettes 10133, Lot #08I032. This is the only lot number affected by this action. The barcodes for Lot #08I032 were printed… |
| Oct 7, 2008 | Not classified | Z-0484-2009 | Nonconforming Material/Component | ASP has discovered a component defect in some of the UV lamp power supplies used in certain STERRAD NX Sterilizers. This defect can potentially cause the Hydrogen Peroxide Monitor to give inaccurate readings. |
| Feb 25, 2008 | Not classified | Z-1631-2008 | 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." |
| Nov 12, 2007 | Not classified | Z-0844-2008 | Other | Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K102330 (STERIS Corporation, 2011) has gone furthest, with 21 descendants of its own.
How does its category compare?
All MLR devicesMLR Sterilizer, Chemical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 (284 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*
† 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.
Note: With the exception of the 1 x 850 mm flexible endoscopes, the 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042116: Sterrad NX Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042116
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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