510(k) · Cleared
Clearedenspire 3000 Cleaning and Liquid Chemical Sterile Processing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · FEB Accessories, Cleaning, For Endoscope
Cleared on Jun 30, 2023 as substantially equivalent to K152189 (Advanced Sterilization Products (Asp), 2016) and 1 other predicate after an 88-day review. Its family tree reaches back 8 generations to 2016. 1 later device descends from it.
- Decided
- Jun 30, 2023
- Review
- 88 days
- Class
- Class II
- Product code
- FEB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K161683 (2016). 17 ancestors in all, the oldest K914145 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK161683 SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2016
- 7 generations backK170956 SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2017
- 6 generations backK173256 System 1 endo Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2018
- 5 generations backK182827 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900STERIS Corporation · 2019
- 4 generations backK191343 SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900STERIS Corporation · 2019
- 3 generations backK192929 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2019
- 2 generations backK210737 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2021
- 1 generation backK211607 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2021
- This deviceK230930 enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS Corporation · 2023
- Descendant · cites it directly · 0 of its ownK243433 enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2024
Most influential descendants
Showing 1 of 1 · See all- K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K161683 | SYSTEM 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2016 | — |
| −7 | K170956 | SYSTEM 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2017 | — |
| −6 | K173256 | System 1 endo Liquid Chemical Sterilant Processing System | STERIS Corporation | 2018 | — |
| −5 | K182827 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 | STERIS Corporation | 2019 | — |
| −4 | K191343 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 | STERIS Corporation | 2019 | — |
| −3 | K192929 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid… | STERIS Corporation | 2019 | — |
| −2 | K210737 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid… | STERIS Corporation | 2021 | — |
| −1 | K211607 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid… | STERIS Corporation | 2021 | — |
| 0 (this device) | K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | STERIS Corporation | 2023 | — |
| +1 | K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | STERIS Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 FEB? 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 FEB device
- #1 K243433 enspire 3000 Cleaning and Liquid Chemical…score 10.8 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K152189 | Evotech EcrSummary page 5…Classification Number: 21 CFR 876.1500 Product Code: FEB 2. Predicate Device EVOTECH Endoscope Cleaner and Reprocessor, K152189 Reference Device: SYSTEM 1 endo Liquid Chemical Sterilant Processing System, K210737 3. Description of Device… | 2016 |
| * | K211607 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…Summary page 14…Comparison S40 Sterilant Concentrate S40 Sterilant Concentrate (K211607) The SYSTEM 1E Processor uses only The SYSTEM 1E Processor uses only Indications for… | 2021 |
| † | K210737 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | 2024 | 0 |
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 7 years and passes through 1 company; a new generation was cleared every 11 months on median.
- 6 of the 17 ancestors have a recall of any class.
- Of its descendants, K243433 (STERIS Corporation, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FEB devicesFEB Accessories, Cleaning, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FEB
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FEB
111in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FEB
15so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FEB
356in 2025
MAUDE reports naming product code FEB, 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 | — | 0 | 39 |
| 2008 | 1 | — | 3 | 152 |
| 2009 | 1 | — | 0 | 20 |
| 2010 | 2 | — | 1 | 50 |
| 2011 | 3 | 111 | 0 | 32 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 1 | — | 0 | 27 |
| 2014 | 1 | — | 0 | 48 |
| 2015 | 0 | — | 0 | 92 |
| 2016 | 2 | — | 2 | 103 |
| 2017 | 2 | — | 0 | 69 |
| 2018 | 1 | — | 0 | 88 |
| 2019 | 2 | — | 0 | 62 |
| 2020 | 2 | — | 1 | 426 |
| 2021 | 0 | — | 1 | 575 |
| 2022 | 1 | — | 0 | 607 |
| 2023 | 1 | — | 1 | 998 |
| 2024 | 2 | — | 1 | 884 |
| 2025 | 0 | — | 3 | 356 |
| 2026 | 1 | — | 15 | — |
What is it indicated for?
The enspire™ 3000 Series Cleaning and Liquid Chemical Sterilant Processing System is intended to effectively provide a pressure monitor, clean, provide liquid chemical sterilization, rinse, and air purge validated immersible, reusable, semi-critical, heat sensitive medical devices such as flexible endoscopes and their accessories. The validated cleaning process replaces cleaning for endoscopes other than duodenoscopes. Manual cleaning of duodenoscopes…
Read the full statement (139 words)
The enspire™ 3000 Series Cleaning and Liquid Chemical Sterilant Processing System is intended to effectively provide a pressure monitor, clean, provide liquid chemical sterilization, rinse, and air purge validated immersible, reusable, semi-critical, heat sensitive medical devices such as flexible endoscopes and their accessories.
The validated cleaning process replaces cleaning for endoscopes other than duodenoscopes. Manual cleaning of duodenoscopes according to the manufacturer’s written instructions for use is required prior to placement in the enspire™ 3000 Series Processor.
The enspire™ 3000 Series Processor uses only Revital-Ox 2X Concentrate Enzymatic detergent to clean and S40 Sterilant Concentrate to liquid chemically sterilize medical devices. It automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46.6 to 55°C and rinses the load with 0.2-micron filtered water.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230930: enspire 3000 Cleaning and Liquid Chemical Sterile Processing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230930
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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