510(k) · Cleared
ClearedMidmark M4*9 Easyclave Steam Sterilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Midmark Corp. · FLE Sterilizer, Steam
Cleared on Jan 10, 2000 as substantially equivalent to K990189 (Midmark Corp., 1999) after a 147-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Jan 10, 2000
- Review
- 147 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K936181 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK936181 Midmark M-11 Ultraclave Steam SterilizerMidmark Corp. · 1994 · Recalled
- 1 generation backK990189 Modification of: Midmark M-11 Ultraclave Steam SterilizerMidmark Corp. · 1999
- This deviceK992744 Midmark M4*9 Easyclave Steam SterilizerMidmark Corp. · 2000
- Descendant · cites it directly · 0 of its ownK024133 CLS-2000 UnitDentsply Intl. · 2003
Most influential descendants
Showing 1 of 1 · See all- K024133CLS-2000 UnitDentsply Intl. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K936181 | Midmark M-11 Ultraclave Steam Sterilizer | Midmark Corp. | 1994 | 1 |
| −1 | K990189 | Modification of: Midmark M-11 Ultraclave Steam Sterilizer | Midmark Corp. | 1999 | — |
| 0 (this device) | K992744 | Midmark M4*9 Easyclave Steam Sterilizer | Midmark Corp. | 2000 | — |
| +1 | K024133 | CLS-2000 Unit | Dentsply Intl. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 FLE? 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 FLE device
- #1 K250168 Life Ultra 25L Tabletop Mono Chamber Steam…score 12.7 · 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 |
|---|---|---|---|
| * | K990189 | Modification of: Midmark M-11 Ultraclave Steam SterilizerSummary page 1…M4+9 EasyClave Steam Sterilizer claims equivalence: Midmark M-11 UltraClave Steam Sterilizer with dental handpiece indications for use, cleared for marketing 4/19/99 on K990189 ' Device Description: The Midmark M4+9 EasyClave Steam Sterilizer uses saturated steam at high pressures and temperatures and t… | 1999 |
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 |
|---|---|---|---|
| K024133 | CLS-2000 Unit | 2003 | 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 6 years and passes through 1 company; a new generation was cleared every 4.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K024133 (Dentsply Intl., 2003) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K990189.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FLE
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLE
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLE
71in 2025
MAUDE reports naming product code FLE, 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 | 5 | 67 | 1 | 19 |
| 2008 | 1 | — | 1 | 21 |
| 2009 | 8 | 109 | 0 | 19 |
| 2010 | 2 | — | 0 | 20 |
| 2011 | 5 | 141 | 1 | 63 |
| 2012 | 5 | 111 | 1 | 69 |
| 2013 | 5 | 241 | 2 | 112 |
| 2014 | 2 | — | 0 | 113 |
| 2015 | 3 | 302 | 1 | 68 |
| 2016 | 1 | — | 0 | 76 |
| 2017 | 3 | 233 | 0 | 63 |
| 2018 | 8 | 146 | 1 | 90 |
| 2019 | 5 | 192 | 2 | 91 |
| 2020 | 2 | — | 0 | 87 |
| 2021 | 5 | 147 | 1 | 81 |
| 2022 | 10 | 133 | 0 | 70 |
| 2023 | 7 | 88 | 0 | 66 |
| 2024 | 2 | — | 0 | 64 |
| 2025 | 4 | 184 | 0 | 71 |
| 2026 | 3 | 85 | 1 | — |
What is it indicated for?
The M4+9 EasyClave is to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable items (including dental handpieces) that are compatible with steam sterilization at 270°F. Refer to Standard Cycle Parameters below for detailed information. Standard Cycle Parameters Cycle Temp/Press/Time Items to be Sterilized (minimums) (Always consult the item manufacturer’s…
Read the full statement (168 words)
The M4+9 EasyClave is to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable items (including dental handpieces) that are compatible with steam sterilization at 270°F. Refer to Standard Cycle Parameters below for detailed information.
Standard Cycle Parameters
Cycle Temp/Press/Time Items to be Sterilized
(minimums) (Always consult the item manufacturer’s recommendations for sterilization.)
Unwrapped 132°C (270°F)/ Instruments and dental handpieces loose on a tray. 186 kPa (27 psi) Open glass or metal canisters. Cassettes. Tubing 3:30 minutes not used in surgical procedures. Items that are compatible with a maximum temperature of 135° C (276° F). The sterility of unwrapped items is compromised on exposure to a non-sterile environment.
Wrapped 132°C (270°F)/ Instruments and dental handpieces. Loosely 186 kPa (27 psi) wrapped individual instruments. Multiple layers of 9 minutes instruments separated by fabric. Wrapped trays of loose instruments. Wrapped cassettes. Tubing not used in surgical procedures. Items that are compatible with a maximum temperature of 135°C (276°F).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992744 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992744: Midmark M4*9 Easyclave Steam Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992744
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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