510(k) Report

510(k) · Cleared

Cleared

STERRAD NX with ALLClear Technology

K220404510(k) TraditionalCleared May 16, 202291-day reviewClass II21 CFR 880.6860

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Advanced Sterilization Products, Inc. · MLR Sterilizer, Chemical

Cleared on May 16, 2022 as substantially equivalent to K160818 (Advanced Sterilization Products, 2016) after a 91-day review. Its family tree reaches back 5 generations to 2005.

Decided
May 16, 2022
Review
91 days
Class
Class II
Product code
MLR
Recalls
None
Predicates
1

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.

  1. Root · 5 generations backK042116 Sterrad NX SterilizerAdvanced Sterilization Products · 2005 · Recalled
  2. 4 generations backK071385 Sterrad 100NX SterilizerAdvanced Sterilization Products · 2007 · Recalled
  3. 3 generations backK092622 Sterrad 100NX Sterilizer Express CycleAdvanced Sterilization Products · 2011
  4. 2 generations backK142454 STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products · 2015 · Recalled
  5. 1 generation backK160818 STERRAD® NX Sterilizer with ALLClear™ TechnologyAdvanced Sterilization Products · 2016
  6. This deviceK220404 STERRAD NX with ALLClear TechnologyAdvanced Sterilization Products, Inc. · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K042116Sterrad NX SterilizerAdvanced Sterilization Products200510
−4K071385Sterrad 100NX SterilizerAdvanced Sterilization Products20075
−3K092622Sterrad 100NX Sterilizer Express CycleAdvanced Sterilization Products2011—
−2K142454STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products20152
−1K160818STERRAD® NX Sterilizer with ALLClear™ TechnologyAdvanced Sterilization Products2016—
0 (this device)K220404STERRAD NX with ALLClear TechnologyAdvanced Sterilization Products, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200320
201210
FIG. 1 — Lineage of K220404, 2005–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250802 STERRAD® 100NX Sterilizer with ALLClear™…score 14.0 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K160818STERRAD® NX Sterilizer with ALLClear™ Technology
Summary page 5
…Class II Product Code: MLR CFR Section: 21 CFR 880.6860 Predicate Device STERRAD® NX Sterilizer with ALLClear® Technology cleared via 510(k) K160818 on September 27, 2016. Device Description The STERRAD NX Sterilizer is a self‐contained stand‐alone system of hardware and softw…
Advanced Sterilization Products2016—

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 17 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
  • 8 of the 10 ancestors have a recall of any class.

How does its category compare?

All MLR devices

MLR Sterilizer, Chemical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · MLR

1in 2025

2007: 22009: 12011: 62012: 22013: 12014: 22015: 12016: 42017: 22018: 22019: 42021: 22022: 22023: 52024: 32025: 12026 (partial year): 1
2007high 6 (2011) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MLR

216in 2024

2011: 214 days median2016: 183 days median2019: 90 days median2023: 222 days median2024: 216 days median
2007high 222 (2023) · low 90 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MLR

1in 2017

2007: 52008: 82009: 22010: 12011: 22012: 32013: 92014: 32017: 1
2007high 9 (2013) · low 0 (2015)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MLR

46in 2025

2007: 2722008: 5362009: 4332010: 2112011: 342012: 1012013: 5412014: 3992015: 4122016: 2862017: 2792018: 2892019: 2222020: 1742021: 2022022: 1882023: 1402024: 442025: 46
2007high 541 (2013) · low 34 (2011)2025

MAUDE reports naming product code MLR, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—5272
20080—8536
20091—2433
20100—1211
20116214234
20122—3101
20131—9541
20142—3399
20151—0412
201641830286
20172—1279
20182—0289
20194900222
20200—0174
20212—0202
20222—0188
202352220140
20243216044
20251—046
20261—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 (442 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.†

• Single-channel stainless steel lumens with an inside diameter of 2 mm or larger and a length of 400 mm or shorter.†

†The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Your loads should not exceed the maximum number of lumens validated by this testing.

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 PE/PTFE flexible endoscopes with an inside diameter of 1 mm or larger and a length of 1065 mm or shorter.*

Note: With the exception of the flexible endoscopes, the validation studies were performed using a validation load consisting of devices in one instrument tray weighing 10.7 lbs (4.9 kg). The flexible endoscopes were validated without any additional load.**

†The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Your loads should not exceed the maximum number of lumens validated by this testing.

* Only one flexible endoscope up to 1065 mm long with or without APTIMAX Instrument Tray Holders can be used per cycle, or only one flexible endoscope up to 850 mm long per cycle with or without a STERRAD Instrument Tray Mat. No additional load. Check the medical device manufacturer’s instructions for use prior to processing any scope in the STERRAD NX Sterilizer; and check if Instrument tray mats or only tray holders are validated for use with flexible endoscopes longer than 850 mm.

**The validation testing for flexible endoscopes up to 850 mm long was conducted with one endoscope per cycle using a STERRAD Instrument Tray Mat to help protect the endoscope no additional load. The validation testing for flexible endoscopes longer that 850 mm was conducted with one endoscope per cycle using APTIMAX Instrument Tray Holders to assist with device placement and help protect the endoscope: no additional load.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K220404: STERRAD NX with ALLClear Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K220404

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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