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. · FRG Wrap, Sterilization
Cleared on Jul 20, 2011 as substantially equivalent to K051242 (Winner Medical (Usa), Inc., 2005) after a 113-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Jul 20, 2011
- Review
- 113 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K990567 (1999). No later device cites it as a predicate yet.
- Root · 3 generations backK990567 Global Healthcare Self-Sealing Sterilization PouchGlobal Healthcare, Inc. · 1999
- 2 generations backK993764 Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co. · 1999
- 1 generation backK051242 Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc. · 2005
- This deviceK110867 Steri-Dent, Steri-SureCpac, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K990567 | Global Healthcare Self-Sealing Sterilization Pouch | Global Healthcare, Inc. | 1999 | — |
| −2 | K993764 | Medipack See-Through Seal Sterilization Pouch | Medipack Medical Packaging Mfg. Co. | 1999 | — |
| −1 | K051242 | Winner Self Seal Sterilization Pouch | Winner Medical (Usa), Inc. | 2005 | — |
| 0 (this device) | K110867 | 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 FRG? 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 FRG device
- #1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 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 |
|---|---|---|---|
| * | K051242 | Winner Self Seal Sterilization PouchSummary page 2…stantially equivalent to the Winner Self Seal Sterilization Pouch both of which are.single use sterilization wraps. The predicate device is legally marketed under 510(k) K051242. Device Description The Steri-Dent Self-Seal Nylon Pouches are single use sterilization wraps that provide a means for health ca… | 2005 |
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 12 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 3 ancestors has a recall.
- 4 other devices also cite its predicate K051242.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FRG
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRG
151in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRG
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRG
18in 2025
MAUDE reports naming product code FRG, 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 | 3 | 182 | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 4 | 171 | 0 | 2 |
| 2010 | 4 | 213 | 0 | 0 |
| 2011 | 6 | 110 | 0 | 12 |
| 2012 | 10 | 133 | 0 | 4 |
| 2013 | 6 | 146 | 2 | 5 |
| 2014 | 8 | 177 | 0 | 13 |
| 2015 | 12 | 196 | 0 | 9 |
| 2016 | 9 | 131 | 0 | 20 |
| 2017 | 9 | 260 | 29 | 7 |
| 2018 | 5 | 150 | 0 | 22 |
| 2019 | 9 | 258 | 0 | 10 |
| 2020 | 5 | 122 | 14 | 21 |
| 2021 | 4 | 170 | 0 | 9 |
| 2022 | 9 | 217 | 2 | 4 |
| 2023 | 9 | 230 | 0 | 13 |
| 2024 | 11 | 182 | 0 | 21 |
| 2025 | 9 | 151 | 0 | 18 |
| 2026 | 4 | 247 | 0 | — |
What is it indicated for?
The Steri-Dent / Steri-Sure Self-Seal Nylon Pouch is intended to be used to allow sterilization of enclosed medical instruments by a dry heat sterilizer operating at 160°C (320°F) for 1 hour (60 minutes) and also to maintain the sterility of the enclosed instruments for 30 days after sterilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110867: 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/K110867
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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