510(k) · Cleared
ClearedImax 9.5 Sterilizers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dental X Srl · FLE Sterilizer, Steam
Cleared on Sep 5, 2006 as substantially equivalent to K945117 (Pelton & Crane Co., 1997) and 1 other predicate after a 355-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Sep 5, 2006
- Review
- 355 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K936181 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK936181 Midmark M-11 Ultraclave Steam SterilizerMidmark Corp. · 1994 · Recalled
- 2 generations backK990189 Modification of: Midmark M-11 Ultraclave Steam SterilizerMidmark Corp. · 1999
- 1 generation backK023348 Midmark M9 Ultraclave Steam SterilizerMidmark Corp. · 2003
- This deviceK052532 Imax 9.5 SterilizersDental X Srl · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K936181 | Midmark M-11 Ultraclave Steam Sterilizer | Midmark Corp. | 1994 | 1 |
| −2 | K990189 | Modification of: Midmark M-11 Ultraclave Steam Sterilizer | Midmark Corp. | 1999 | — |
| −1 | K023348 | Midmark M9 Ultraclave Steam Sterilizer | Midmark Corp. | 2003 | — |
| 0 (this device) | K052532 | Imax 9.5 Sterilizers | Dental X Srl | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (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 |
|---|---|---|---|
| * | K945117 | DELTASummary page 1…5 DS Sterilizer Common/Usual Name: Steam sterilizer Classification Name: Steam sterilizer 3. PREDICATE DEVICES *Delta Steam Sterilizer (K9451 17) *Midmark M9 UltraClave (K023348) 4. DEVICE DESCRIPTION The iMax 9.5 DS Sterilizer is a gravity table-top ste… | 1997 |
| * | K023348 | Midmark M9 Ultraclave Steam SterilizerSummary page 1…Steam sterilizer Classification Name: Steam sterilizer 3. PREDICATE DEVICES *Delta Steam Sterilizer (K9451 17) *Midmark M9 UltraClave (K023348) 4. DEVICE DESCRIPTION The iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer. The iMax 9.5 DS Ster… | 2003 |
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 12 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
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 iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer intended for heat and moisture resistant medical and dental (including complex lumened devices such as dental handpieces) instruments and cloth packs for sterilization in healthcare facilities. Three pre-programmed sterilization cycles are provided with the iMax 9.5 DS Sterilizer (see table below). Cycle | Temperature (°C) | Pressure (bar) | Exposure Time (min.) | Drying Time (min.) |…
Read the full statement (148 words)
The iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer intended for heat and moisture resistant medical and dental (including complex lumened devices such as dental handpieces) instruments and cloth packs for sterilization in healthcare facilities.
Three pre-programmed sterilization cycles are provided with the iMax 9.5 DS Sterilizer (see table below).
Cycle | Temperature (°C) | Pressure (bar) | Exposure Time (min.) | Drying Time (min.) | Maximum Load (kg)
Unwrapped instruments* | 134 | 2.14 - 2.21 | 4 | 6 | 4.0
Wrapped instruments | 134 | 2.14 - 2.21 | 20 | 20 | 4.0
Packs | 121 | 1.10 - 1.17 | 30 | 20 | 1.5
* Not indicated for the processing of complex instruments (ie. containing lumens, hinges, mated surfaces, etc.)
**Dental handpieces can be processed in the Wrapped instruments cycle only
The sterilizer is not intended to sterilize patient-contacting liquids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052532: Imax 9.5 Sterilizers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052532
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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