510(k) · Cleared
ClearedCadd-TPN Administration Set, Model 21-7071
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sims Deltec, Inc. · FPA Set, Administration, Intravascular
Cleared on Jun 9, 1999 as substantially equivalent to K902374 (Pharmacia Deltec, Inc., 1990) and 2 other predicates after a 57-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jun 9, 1999
- Review
- 57 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K902374 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK902374 Cadd-TPN Model 5700 Ambulatory Infusion SystemPharmacia Deltec, Inc. · 1990
- This deviceK991255 Cadd-TPN Administration Set, Model 21-7071Sims Deltec, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902374 | Cadd-TPN Model 5700 Ambulatory Infusion System | Pharmacia Deltec, Inc. | 1990 | — |
| 0 (this device) | K991255 | Cadd-TPN Administration Set, Model 21-7071 | Sims Deltec, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 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 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? (3)
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 |
|---|---|---|---|
| * | K902374 | Cadd-TPN Model 5700 Ambulatory Infusion SystemSummary page 2…th Anti-siphon with TOTM Valve Valve Plasticized Tubing MANUFACTURER SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. 510(K) NUMBER Subject Device K902374 K942046 K933390 INDICATIONS FOR The CADD-TPN® The CADD-TPN® For use with the The CADD® USE Administration Set is Administration S… | 1990 |
| * | K942046 | Pharmacia Deltec Extension Set with Anti-Siphon ValveSummary page 2…siphon with TOTM Valve Valve Plasticized Tubing MANUFACTURER SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. 510(K) NUMBER Subject Device K902374 K942046 K933390 INDICATIONS FOR The CADD-TPN® The CADD-TPN® For use with the The CADD® USE Administration Set is Administration Set is ME… | 1994 |
| * | K933390 | Remote Reservoir Adapter (TM) Cassette with BagSummary page 2…ith TOTM Valve Valve Plasticized Tubing MANUFACTURER SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. 510(K) NUMBER Subject Device K902374 K942046 K933390 INDICATIONS FOR The CADD-TPN® The CADD-TPN® For use with the The CADD® USE Administration Set is Administration Set is MEDICATION… | 1994 |
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?
- 1 of the 3 ancestors has a recall of any class.
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 CADD-TPN® Administration Set is designed for use with the CADD-TPN® pump for the administration of nutritional and other solutions or fluids intravenously from an IV bag.
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/K991255 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991255: Cadd-TPN Administration Set, Model 21-7071.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991255
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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