510(k) · Cleared
Clearedenspire 3000 Cleaning and Liquid Chemical Sterilant 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 Dec 2, 2024 as substantially equivalent to K230930 (STERIS Corporation, 2023) after a 27-day review. Its family tree reaches back 9 generations to 2016.
- Decided
- Dec 2, 2024
- Review
- 27 days
- Class
- Class II
- Product code
- FEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K161683 (2016). 18 ancestors in all, the oldest K914145 (1994). No later device cites it as a predicate yet.
- Root · 9 generations backK161683 SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2016
- 5 generations between
- 3 generations backK210737 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2021
- 2 generations backK211607 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2021
- 1 generation backK230930 enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS Corporation · 2023
- This deviceK243433 enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2024
Show all 9 generations
- Root · 9 generations backK161683 SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2016
- 8 generations backK170956 SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2017
- 7 generations backK173256 System 1 endo Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2018
- 6 generations backK182827 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900STERIS Corporation · 2019
- 5 generations backK191343 SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900STERIS Corporation · 2019
- 4 generations backK192929 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2019
- 3 generations backK210737 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2021
- 2 generations backK211607 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo…STERIS Corporation · 2021
- 1 generation backK230930 enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS Corporation · 2023
- This deviceK243433 enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K161683 | SYSTEM 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2016 | — |
| −8 | K170956 | SYSTEM 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2017 | — |
| −7 | K173256 | System 1 endo Liquid Chemical Sterilant Processing System | STERIS Corporation | 2018 | — |
| −6 | K182827 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 | STERIS Corporation | 2019 | — |
| −5 | K191343 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 | STERIS Corporation | 2019 | — |
| −4 | K192929 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid… | STERIS Corporation | 2019 | — |
| −3 | K210737 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid… | STERIS Corporation | 2021 | — |
| −2 | K211607 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid… | STERIS Corporation | 2021 | — |
| −1 | K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | STERIS Corporation | 2023 | — |
| 0 (this device) | 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 |
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 K230930 enspire 3000 Cleaning and Liquid Chemical…score 10.7 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSummary page 6…21 CFR 876.1500 Product Code: FEB 2. Predicate Device enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System, K230930 3. Description of Device The enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (CLCSPS) is a… | 2023 |
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 8 years and passes through 1 company; a new generation was cleared every 11 months on median.
- 6 of the 18 ancestors have a recall of any class.
How does its category compare?
All FEB devicesFEB Accessories, Cleaning, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 TM 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, semicritical, 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 (142 words)
The enspire TM 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, semicritical, 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 m 3000 Series Processor.
The enspire TM 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 550C and rinses the load with 0.2-micron filtered water.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243433 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243433: enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243433
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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