510(k) · Cleared
ClearedPrestige Medical Series 2100 Clinical Autoclave
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prestige Medical Corp. · FLE Sterilizer, Steam
Cleared on Mar 3, 1998 as substantially equivalent to K910789 (Kavo America, 1991) and 1 other predicate after a 586-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Mar 3, 1998
- Review
- 586 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900432 (1990). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K063681Tecno-Gaz Andromeda Vacuum CS AutoclaveMediline Italia S.R.L. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900432 | Model #M8 Electronic Sterilizer | Midmark Corp. | 1990 | — |
| 0 (this device) | K962903 | Prestige Medical Series 2100 Clinical Autoclave | Prestige Medical Corp. | 1998 | — |
| +1 | K063681 | Tecno-Gaz Andromeda Vacuum CS Autoclave | Mediline Italia S.R.L. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K910789 | Kavoklave Steam AutoclaveSummary page 1…e Proprietary Name: Prestige Medical Series 2100 Clinical Autoclave Common Name: autoclave Classification Name: steam sterilizer Predicates: KaVoKlave Steam Autoclave, K910789 #MS8 Electronic Sterilizer, K900432 Device Description: The Series 2100 clinical autoclaves by Prestige Medical are Model number… | 1991 |
| * | K900432 | Model #M8 Electronic SterilizerSummary page 1…Series 2100 Clinical Autoclave Common Name: autoclave Classification Name: steam sterilizer Predicates: KaVoKlave Steam Autoclave, K910789 #MS8 Electronic Sterilizer, K900432 Device Description: The Series 2100 clinical autoclaves by Prestige Medical are Model numbers 2100 07 (extended body) and 2100 0… | 1990 |
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 |
|---|---|---|---|
| K063681 | Tecno-Gaz Andromeda Vacuum CS Autoclave | 2007 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K063681 (Mediline Italia S.R.L., 2007) has gone furthest, with 0 descendants of its own.
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 Models 2100 06 and 2100 07 Clinical Autoclaves are intended to sterilize
unwrapped solid instruments (i.e., excluding lumened instruments and dental
handpieces) and non-porous loads at cycle parameters of 121" Celsius saturated steam
process for 18 minutes
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/K962903 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962903: Prestige Medical Series 2100 Clinical Autoclave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962903
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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