510(k) · Cleared
ClearedFamily of Steam sterilizers B17 B22 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 Feb 23, 2017 as substantially equivalent to K151597 (Cefla S.C., 2016) after a 233-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Feb 23, 2017
- Review
- 233 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K003470 (2001). 16 ancestors in all, the oldest K850264 (1985). No later device cites it as a predicate yet.
- Root · 7 generations backK003470 Ehs Series Table Top Autoclave, Models 2540 and 3870Tuttnauer Co., Ltd. · 2001
- 6 generations backK032192 Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door…Tuttnauer U.S.A Co, Ltd. · 2004
- 5 generations backK063711 Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120…Tuttnauer Co., Ltd. · 2007
- 4 generations backK090783 Tuttnauer Elara-11 Pre-Vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2009
- 3 generations backK111736 Tuttnauer EZ Plus Series Electronic Tabletop AutoclavesTuttnauer Co., Ltd. · 2011
- 2 generations backK143311 Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2015
- 1 generation backK151597 Family of Steam Sterilizers B 28 seriesCefla S.C. · 2016
- This deviceK161848 Family of Steam sterilizers B17 B22 SeriesCefla S.C. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003470 | Ehs Series Table Top Autoclave, Models 2540 and 3870 | Tuttnauer Co., Ltd. | 2001 | — |
| −6 | K032192 | Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door, Models… | Tuttnauer U.S.A Co, Ltd. | 2004 | — |
| −5 | K063711 | Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120 SP-1A… | Tuttnauer Co., Ltd. | 2007 | — |
| −4 | K090783 | Tuttnauer Elara-11 Pre-Vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2009 | — |
| −3 | K111736 | Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves | Tuttnauer Co., Ltd. | 2011 | — |
| −2 | K143311 | Pre-vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2015 | — |
| −1 | K151597 | Family of Steam Sterilizers B 28 series | Cefla S.C. | 2016 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K151597 | Family of Steam Sterilizers B 28 seriesSummary page 15…device: Applicant Device name 510(k) Number CEFLA S.C. Family of steam sterilizers B28 series K151597 Page 1 CEFLA SC… | 2016 |
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 16 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 16 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. 2017, 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?
B CLASSIC-17 is a steam sterilizer that is intended for use by a health care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products. B CLASSIC-22 is a steam sterilizer that is intended for use by a…
Read the full statement (236 words)
B CLASSIC-17 is a steam sterilizer that is intended for use by a health care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
B CLASSIC-22 is a steam sterilizer that is intended for use by a health care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
B FUTURA-17 is a steam sterilizer that is intended for use by a health care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
B FUTURA-22 is a steam sterilizer that is intended for use by a health care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process.
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/K161848 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161848: Family of Steam sterilizers B17 B22 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161848
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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