510(k) · Cleared
Recalled · 2005Cadd Administration Set
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 15, 1999 as substantially equivalent to K943310 (Pharmacia Deltec, Inc., 1995) after a 36-day review. Its family tree reaches back 1 generation to 1995. It has been recalled 32 times.
- Decided
- Jun 15, 1999
- Review
- 36 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 32
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943310 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK943310 Model 6100 Ambulatory Infusion SystemPharmacia Deltec, Inc. · 1995
- This deviceK991599 Cadd Administration SetSims Deltec, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943310 | Model 6100 Ambulatory Infusion System | Pharmacia Deltec, Inc. | 1995 | — |
| 0 (this device) | K991599 | Cadd Administration Set | Sims Deltec, Inc. | 1999 | — |
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? (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 |
|---|---|---|---|
| * | K943310 | Model 6100 Ambulatory Infusion SystemSummary page 2…RASITE™ Needle- Administration Sets Administration Set free IV System MANUFACTURER SIMS Deltec, Inc. SIMS Deltec, Inc, B. Braun Medjcal Inc. 510(K) NUMBER Subject Device K943310 Unknown INDICATIONS FOR USE Designed for use with Designed for use with The ULTRASITE™ Valve vatious SIMS Deltec various SIMS Del… | 1995 |
| * | — | ULTRASITE™ Needle-free IV System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 8, 2005 | Not classified | Z-0658-06 | Other | Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely. |
| Dec 8, 2005 | Not classified | Z-0659-06 | Other | Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely. |
| Dec 8, 2005 | Not classified | Z-0660-06 | Other | Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely. |
| Dec 3, 2004 | Not classified | Z-0465-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0466-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0464-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0468-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0469-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0472-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0474-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0467-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0470-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0471-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0479-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0473-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0484-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0485-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0475-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0476-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0477-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0478-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0480-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0481-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0482-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0486-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0487-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0483-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0489-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0490-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0491-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0492-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
| Dec 3, 2004 | Not classified | Z-0488-05 | Other | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to… |
The 5 latest of 32 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K943310.
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
2007high 23 (2010) · low 4 (2018)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
2007high 340 (2023) · low 75 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
2007high 166 (2009) · low 1 (2021)2026
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
2007high 47,210 (2024) · low 1,499 (2007)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 luer activated needleless injection site is designed for use with various SIMS Deltec, Inc. administration sets or syringes for fluid delivery.
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/K991599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991599: Cadd Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991599
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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