510(k) · Cleared
ClearedFamily of Steam Sterilizers B 28 series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cefla S.C. · FLE Sterilizer, Steam
Cleared on Mar 4, 2016 as substantially equivalent to K050263 (M.O. Com S.R.L., 2006) and 1 other predicate after a 266-day review. Its family tree reaches back 6 generations to 2001. 1 later device descends from it.
- Decided
- Mar 4, 2016
- Review
- 266 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K003470 (2001). 15 ancestors in all, the oldest K850264 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK003470 Ehs Series Table Top Autoclave, Models 2540 and 3870Tuttnauer Co., Ltd. · 2001
- 5 generations backK032192 Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door…Tuttnauer U.S.A Co, Ltd. · 2004
- 4 generations backK063711 Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120…Tuttnauer Co., Ltd. · 2007
- 3 generations backK090783 Tuttnauer Elara-11 Pre-Vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2009
- 2 generations backK111736 Tuttnauer EZ Plus Series Electronic Tabletop AutoclavesTuttnauer Co., Ltd. · 2011
- 1 generation backK143311 Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2015
- This deviceK151597 Family of Steam Sterilizers B 28 seriesCefla S.C. · 2016
- Descendant · cites it directly · 0 of its ownK161848 Family of Steam sterilizers B17 B22 SeriesCefla S.C. · 2017
Most influential descendants
Showing 1 of 1 · See all- K161848Family of Steam sterilizers B17 B22 SeriesCefla S.C. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003470 | Ehs Series Table Top Autoclave, Models 2540 and 3870 | Tuttnauer Co., Ltd. | 2001 | — |
| −5 | K032192 | Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door, Models… | Tuttnauer U.S.A Co, Ltd. | 2004 | — |
| −4 | K063711 | Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120 SP-1A… | Tuttnauer Co., Ltd. | 2007 | — |
| −3 | K090783 | Tuttnauer Elara-11 Pre-Vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2009 | — |
| −2 | K111736 | Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves | Tuttnauer Co., Ltd. | 2011 | — |
| −1 | K143311 | Pre-vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2015 | — |
| 0 (this device) | K151597 | Family of Steam Sterilizers B 28 series | Cefla S.C. | 2016 | — |
| +1 | K161848 | Family of Steam sterilizers B17 B22 Series | Cefla S.C. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K050263 | Millennium Series, Including Millennium B, B+, B2 and BUSummary page 8…510(k) Number 2 M.O.COM. s.r I MILLENNIUM series (B model) K050263 Tuttnauer USA Co. Tuttnauer Pre-Vacuum Tabletop K143311 Ltd Autoclave (Mode… | 2006 |
| * | K143311 | Pre-vacuum Tabletop AutoclaveSummary page 8…2 M.O.COM. s.r I MILLENNIUM series (B model) K050263 Tuttnauer USA Co. Tuttnauer Pre-Vacuum Tabletop K143311 Ltd Autoclave (Model ELARA-11) 2.4. Intended Use… | 2015 |
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 |
|---|---|---|---|
| K161848 | Family of Steam sterilizers B17 B22 Series | 2017 | 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 15 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K161848 (Cefla S.C., 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K050263.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 Family of steam Sterilizers B 28 series B CLASSIC-28 and B FUTURA-28 models are table top steam sterilizers to be used in medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities to sterilize re-usable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process. The Family of Steam Sterilizers B 28 series is validated…
Read the full statement (137 words)
The Family of steam Sterilizers B 28 series B CLASSIC-28 and B FUTURA-28 models are table top steam sterilizers to be used in medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities to sterilize re-usable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process.
The Family of Steam Sterilizers B 28 series is validated for sterilization of fabric packs/textiles for sterilization programs C1 and C2.
The Family of Steam Sterilizers B 28 series is validated for sterilization up to 9 dental handpieces for sterilization programs C1 and C2.
The Family of Steam Sterilizers B 28 series is validated for sterilization up to 6 lumen devices (specifications in the table below)
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
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/K151597 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151597: Family of Steam Sterilizers B 28 series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151597
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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