510(k) · Cleared
ClearedQuantim 16 Autoclave
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scican · FLE Sterilizer, Steam
Cleared on Aug 8, 2002 as substantially equivalent to K990189 (Midmark Corp., 1999) after a 128-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Aug 8, 2002
- Review
- 128 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K936181 (1994). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 Sterilizer | 1999 |
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 2 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 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 QUANTlM 16 tabletop autoclave is a gravity steam autoclave designed to process medical and dental instruments to achieve successful sterilization in a clinical setting. It utilizes saturated stearn at high pressures in order to attain an effective kill of infectious bio-organisms and prevent cross infection. The unit is intended to sterilize heat and moisture stable medical and dental instruments (including dental handpieces) which are commonly found…
Read the full statement (258 words)
The QUANTlM 16 tabletop autoclave is a gravity steam autoclave designed to process medical and dental instruments to achieve successful sterilization in a clinical setting. It utilizes saturated stearn at high pressures in order to attain an effective kill of infectious bio-organisms and prevent cross infection.
The unit is intended to sterilize heat and moisture stable medical and dental instruments (including dental handpieces) which are commonly found in medical and dental offices, hospitals, clinics, and other facilities. The instruments must be suitable for steam sterilization at 132°C (270°F). Two additional cycles are also specified for (i) the sterilimtion of textiles and wrapped surgical packs and (ii) liquid loads contained in open top glass flasks. Hovever, the QUANTIM 16 Table-top Autoclave is not intended nor recommended for sterilization of liquids intended for direct patient contact.
The sterilization cycles as to established time, temperatures, load configurations, drying time and indicated uses for the QUANTM 16 Table-top Autoclave are as follows:
CYCLE | STERILIZATION TEMPERATURE | MAXMUM LOAD | STERILIZATION TIME | DRYING TIME | INTENDED USE
Unwrapped | 133°C (270°F) | 2k-g (4.41bs) | 3 min. | 30 min. | Flash cycle for solid and hinged instruments, dental handpieces
Wrapped | 132°C (270°F) | lkg (2.21bs) | 15 min. | 30 min. | Solid and hinged instruments, dental handpieces
Packs | 121”~ (250°F) | Ikg (2.21bs) | 30 rnin. | 30 rnin. | Textiles and wrapped surEical~packs
Liquids | | | 30 rnin. | N/A (no drying phase) | Liquids suitable for sterilization in open top flasks (not intended for
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021064: Quantim 16 Autoclave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021064
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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