510(k) · Cleared
Recalled · Class II · 2014Sterrad 50 & Sterrad 100S Sterilizers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Sterilization Products · FLF Sterilizer, Ethylene-Oxide Gas
Cleared on Apr 3, 2003 as substantially equivalent to K981625 (Advanced Sterilization Products, 1999) and 1 other predicate after a 183-day review. Its family tree reaches back 1 generation to 1999. 18 later devices descend from it. It has been recalled 9 times.
- Decided
- Apr 3, 2003
- Review
- 183 days
- Class
- Class II
- Product code
- FLF
- Recalls
- 9
- Predicates
- 2
Its longest line of descent runs back 1 generation to K981625 (1999). 2 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK981625 Sterrad 50 SterilizerAdvanced Sterilization Products · 1999 · Recalled
- This deviceK023290 Sterrad 50 & Sterrad 100S SterilizersAdvanced Sterilization Products · 2003
- Descendant · cites it directly · 17 of its ownK111377 Sterrad (R) 100NX Sterilizer Duo CycleAdvanced Sterilization Products · 2012 · Recalled
- Descendant · 2 generations on · 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 · 2 generations on · 4 of its ownK160903 STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products · 2016
- Descendant · 3 generations on · 4 of its ownK153392 STERIZONE VP4 SterilizerTs03, Inc. · 2016
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K111377Sterrad (R) 100NX Sterilizer Duo CycleAdvanced Sterilization Products · 2012 · cites it directly17descendants
- K142454STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products · 2015 · 2 generations on9descendants
- K141163Sterizone SterilizerTso3, Inc. · 2014 · 2 generations on5descendants
- K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products · 2016 · 2 generations on4descendants
- K153392STERIZONE VP4 SterilizerTs03, Inc. · 2016 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981625 | Sterrad 50 Sterilizer | Advanced Sterilization Products | 1999 | 5 |
| 0 (this device) | K023290 | Sterrad 50 & Sterrad 100S Sterilizers | Advanced Sterilization Products | 2003 | — |
| +1 | K111377 | Sterrad (R) 100NX Sterilizer Duo Cycle | Advanced Sterilization Products | 2012 | 1 |
| +2 | K142454 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | Advanced Sterilization Products | 2015 | 2 |
| +2 | K141163 | Sterizone Sterilizer | Tso3, Inc. | 2014 | — |
| +2 | K160903 | STERRAD 100NX Sterilizer with ALLClearTM Technology | Advanced Sterilization Products | 2016 | — |
| +3 | K153392 | STERIZONE VP4 Sterilizer | Ts03, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 FLF? 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 FLF device
- #1 K192978 EOGas 4 Ethylene Oxide Gas Sterilizerscore 0.6 · 2 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K981625 | Sterrad 50 SterilizerSummary page 1…e: STERRAD@50 Sterilization System and STERRAD@100s Sterilization System 2.0 PREDICATE DEVICES STERRAD@ 50 Sterilization System (K98 1625) and STERRAD@ 100s Sterilization System (K99 1999) 3.0 INDICATIONS FOR USE This Premarket Notification is to… | 1999 |
| * | K991999 | Sterrad 100S SterilizerSummary page 1…Sterilization System 2.0 PREDICATE DEVICES STERRAD@ 50 Sterilization System (K98 1625) and STERRAD@ 100s Sterilization System (K99 1999) 3.0 INDICATIONS FOR USE This Premarket Notification is to expand the Indications for Use for the STERRAD 50… | 2000 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111377 | Sterrad (R) 100NX Sterilizer Duo Cycle | 2012 | 17 |
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-0842-2015 | 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. |
| Nov 4, 2014 | Class II | Z-0843-2015 | 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. |
| Dec 16, 2013 | Class II | Z-0745-2014 | 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. |
| Dec 16, 2013 | Class II | Z-0746-2014 | 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. |
| Mar 9, 2009 | Not classified | Z-1419-2009 | 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. |
| Oct 17, 2008 | Not classified | Z-0340-2009 | Component design/selection | 1) Inability of the sterilizer to detect when an injection takes place without hydrogen peroxide being transferred to the vaporizer bowl. This situation can result in a cycle completion with the injection of insufficient hydrogen peroxide… |
| Feb 25, 2008 | Not classified | Z-1629-2008 | 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." |
| Feb 25, 2008 | Not classified | Z-1628-2008 | 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." |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K111377 (Advanced Sterilization Products, 2012) has gone furthest, with 17 descendants of its own.
How does its category compare?
All FLF devicesFLF Sterilizer, Ethylene-Oxide Gas: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FLF
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · FLF
Too few FLF 510(k)s in any year since 2007 to give a median.
Recalls per year · FLF
2in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLF
4in 2021
MAUDE reports naming product code FLF, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 1 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 1 | 5 |
| 2013 | 0 | — | 2 | 3 |
| 2014 | 0 | — | 2 | 6 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This Premarket Notification is to expand the Indications for Use for the STERRAD 50 Sterilizer (K981625) and the STERRAD 100s Sterilizer (K991999) to include titanium as a compatible material and to expand the lumen sizes to include medical devices with only a single stainless steel lumen in the following configurations: An inside diameter of 1 mm or larger and a length of 125 mm or shorter An inside diameter of 2 mm or larger and a length of 250 mm or…
Read the full statement (130 words)
This Premarket Notification is to expand the Indications for Use for the STERRAD 50 Sterilizer (K981625) and the STERRAD 100s Sterilizer (K991999) to include titanium as a compatible material and to expand the lumen sizes to include medical devices with only a single stainless steel lumen in the following configurations:
An inside diameter of 1 mm or larger and a length of 125 mm or shorter
An inside diameter of 2 mm or larger and a length of 250 mm or shorter
The validation testing for these two new lumen sizes was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.
For information pertaining to previously cleared materials and lumen sizes, please reference K981625 and K991999.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023290: Sterrad 50 & Sterrad 100S Sterilizers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023290
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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