510(k) · Cleared
ClearedAdr Thinset Infusion Set Model, 23-106, 23-109, 43-106, 43-109
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Diabetes Research, Incorporated · FPA Set, Administration, Intravascular
Cleared on Oct 16, 2003 as substantially equivalent to K012429 (Applied Diabetes Research, Incorporated, 2001) after a 17-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Oct 16, 2003
- Review
- 17 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K991979 (1999). No later device cites it as a predicate yet.
- Root · 2 generations backK991979 Sof-Set Micro QR Infusion Set, Models 320 and 321Medtronic Minimed · 1999
- 1 generation backK012429 Sureset Infusion Set, Model 8023Applied Diabetes Research, Incorporated · 2001
- This deviceK033099 Adr Thinset Infusion Set Model, 23-106, 23-109, 43-106, 43-109Applied Diabetes Research, Incorporated · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991979 | Sof-Set Micro QR Infusion Set, Models 320 and 321 | Medtronic Minimed | 1999 | — |
| −1 | K012429 | Sureset Infusion Set, Model 8023 | Applied Diabetes Research, Incorporated | 2001 | — |
| 0 (this device) | K033099 | Adr Thinset Infusion Set Model, 23-106, 23-109, 43-106, 43-109 | Applied Diabetes Research, Incorporated | 2003 | — |
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 FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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 |
|---|---|---|---|
| * | K012429 | Sureset Infusion Set, Model 8023 | 2001 |
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 4 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The ADR THINSet Infusion Set is intended for the subcutaneous infusion
of medicine, including insulin, from an external infusion pump. The set is
not intended nor indicated for use with blood or blood products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033099 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033099: Adr Thinset Infusion Set Model, 23-106, 23-109, 43-106, 43-109.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033099
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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