510(k) · Cleared
ClearedWire Sterilization Package with Indicators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Orthodontics · FRG Wrap, Sterilization
Cleared on Oct 29, 2015 as substantially equivalent to K112591 (Safe Secure Packaging Co., Ltd., 2012) and 1 other predicate after a 364-day review. Its family tree reaches back 5 generations to 1999.
- Decided
- Oct 29, 2015
- Review
- 364 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K990567 (1999). 6 ancestors in all, the oldest K951113 (1996). No later device cites it as a predicate yet.
- Root · 5 generations backK990567 Global Healthcare Self-Sealing Sterilization PouchGlobal Healthcare, Inc. · 1999
- 4 generations backK993764 Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co. · 1999
- 3 generations backK051242 Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc. · 2005
- 2 generations backK062704 Sterilization Pouch with IndicatorsWinner Industries (Shenzhen) Co., Ltd. · 2007
- 1 generation backK112591 Safe Secure Sterilization Pounch with Steam and Ethylene Oxide…Safe Secure Packaging Co., Ltd. · 2012
- This deviceK143117 Wire Sterilization Package with IndicatorsAmerican Orthodontics · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990567 | Global Healthcare Self-Sealing Sterilization Pouch | Global Healthcare, Inc. | 1999 | — |
| −4 | K993764 | Medipack See-Through Seal Sterilization Pouch | Medipack Medical Packaging Mfg. Co. | 1999 | — |
| −3 | K051242 | Winner Self Seal Sterilization Pouch | Winner Medical (Usa), Inc. | 2005 | — |
| −2 | K062704 | Sterilization Pouch with Indicators | Winner Industries (Shenzhen) Co., Ltd. | 2007 | — |
| −1 | K112591 | Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process… | Safe Secure Packaging Co., Ltd. | 2012 | — |
| 0 (this device) | K143117 | Wire Sterilization Package with Indicators | American Orthodontics | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 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? (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 |
|---|---|---|---|
| * | K112591 | Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process IndicatorsSummary page 4…eam and Ethylene Oxide Process Indicators Manufacturer: Safe Secure Packaging Company, Limited 510(k) #: K112591 Classification Name: Sterilization Wrap Classification Code: FRG Regulation Number (21C… | 2012 |
| * | K951113 | Cross-ChecksSummary page 5…econdary Predicate: Product/Trade Name: Cross‐Checks Indicator Manufacturer: SteriTec Products Mfg. Co., Inc 510(k) #: K951113 Classification Name: Sterilization Process Indicator Classification Code: JOJ… | 1996 |
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 6 companies; a new generation was cleared every 3.7 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K112591.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Wire Sterilization Package with Indicators is intended to be used to enclose and package American Orthodontics’ line of Orthodontic Arch Wires. These packages are shipped unsterile and for single-use only. This packaging offers the health provider (trained dental professional and/or Orthodontist) the option of sterilizing the enclosed arch wire using steam or ethylene oxide gas. The indicators will display a visual color change to signify exposure to…
Read the full statement (170 words)
Wire Sterilization Package with Indicators is intended to be used to enclose and package American Orthodontics’ line of Orthodontic Arch Wires. These packages are shipped unsterile and for single-use only. This packaging offers the health provider (trained dental professional and/or Orthodontist) the option of sterilizing the enclosed arch wire using steam or ethylene oxide gas. The indicators will display a visual color change to signify exposure to steam or ethylene oxide gas and distinguish between processed and unprocessed wire.
STERILIZATION PARAMETERS
Ethylene Oxide [100% E.O.] Gas
1. EO Concentration: 725 mg/L
2. Exposure Temperature: 130°F (55°C)
3. Exposure Time: 1 hour
4. Aeration Time: 8 hours
Upon completion of the process, the EO color indicator will change from Blue to Cocoa Brown.
Steam – Gravity
1. Exposure Temperature: 270°F (132°C)
2. Exposure Time: 15 minutes
3. Dry Time: 30 minutes
Upon completion of the process, the STEAM color indicator will change from Blue to Black/Brownish Black.
Please Note: Upon completion of the process, the archwire is to be used immediately.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143117 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143117: Wire Sterilization Package with Indicators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143117
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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