510(k) · Cleared
ClearedSteri-Dent, Steri-Sure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cpac, Inc. · KMH Sterilizer, Dry Heat
Cleared on Jul 12, 2011 as substantially equivalent to K771070 (Cpac, Inc., 1977) after a 559-day review. Its family tree reaches back 1 generation to 1977.
- Decided
- Jul 12, 2011
- Review
- 559 days
- Class
- Class II
- Product code
- KMH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K771070 (1977). No later device cites it as a predicate yet.
- Root · 1 generation backK771070 Dry Heat SterilizerCpac, Inc. · 1977
- This deviceK094026 Steri-Dent, Steri-SureCpac, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771070 | Dry Heat Sterilizer | Cpac, Inc. | 1977 | — |
| 0 (this device) | K094026 | Steri-Dent, Steri-Sure | Cpac, Inc. | 2011 | — |
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 KMH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K771070 | Dry Heat SterilizerSummary page 2…equivalent to the Steri-Dent Model 200 and 300 both of which are table top dry heat sterilizers currently manufactured by CPAC, Inc and legally marketed under 510O(k) K771 070. Device Description The Model 2100 and 3100 are table-top natural convective (static air type) dry heat sterilizers designed f… | 1977 |
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?
- Its one ancestor has no recall.
How does its category compare?
All KMH devicesKMH Sterilizer, Dry Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KMH
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · KMH
Too few KMH 510(k)s in any year since 2007 to give a median.
Recalls per year · KMH
No recall names KMH since 2007.
Adverse event reports per year · KMH
No MAUDE report names KMH since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Model 2100 and 3100 are table-top natural convective (static air type) dry heat sterilizers designed for use in healthcare facilities for the sterilization of wrapped and unwrapped metal instruments. The single sterilization cycle runs at 160°C (320°F) for 1 hour (60 minutes). The Model 2100 and 3100 are identical in operation and only differ in instrument capacity. The Model 2100 is provided with two (2) trays and the Model 3100 is provided with…
Read the full statement (128 words)
The Model 2100 and 3100 are table-top natural convective (static air type) dry heat sterilizers designed for use in healthcare facilities for the sterilization of wrapped and unwrapped metal instruments. The single sterilization cycle runs at 160°C (320°F) for 1 hour (60 minutes).
The Model 2100 and 3100 are identical in operation and only differ in instrument capacity. The Model 2100 is provided with two (2) trays and the Model 3100 is provided with three (3) trays that are slightly larger in size than the Model 2100 trays. The maximum recommended load for each tray for the Model 2100 is 1.3 lbs including the weight of the tray. For the Model 3100, the maximum recommended load for each tray is 1.4 lbs including the weight of the tray.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K094026 · printed Nov 4, 2026
Cite this page
510(k) Report. “K094026: Steri-Dent, Steri-Sure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K094026
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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