510(k) Report

510(k) · Cleared

Recalled · 2011

Cadd-Prizm High Volume Administration Set with 1.2 U Filter and Add-on Anti-Siphon Valve, Cadd Administration Set with 1

K991301510(k) TraditionalCleared Jun 9, 199954-day reviewClass II21 CFR 880.5440Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sims Deltec, Inc. · FPA Set, Administration, Intravascular

Cleared on Jun 9, 1999 as substantially equivalent to K943310 (Pharmacia Deltec, Inc., 1995) and 2 other predicates after a 54-day review. Its family tree reaches back 1 generation to 1994. It has been recalled once.

Decided
Jun 9, 1999
Review
54 days
Class
Class II
Product code
FPA
Recalls
1
Predicates
3

Its longest line of descent runs back 1 generation to K933390 (1994). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 2 other ancestorsK933390 · Remote Reservoir Adapter (TM) Cassette with Bag · Pharmacia Deltec, Inc. · 1994 · recalled199019921994199619982000
Other ancestors, by generation 1 generation back: 2 other ancestors K933390 · Remote Reservoir Adapter (TM) Cassette with Bag · Pharmacia Deltec, Inc. · 1994 · recalled0
  1. Root · 1 generation backK933390 Remote Reservoir Adapter (TM) Cassette with BagPharmacia Deltec, Inc. · 1994 · Recalled
  2. This deviceK991301 Cadd-Prizm High Volume Administration Set with 1.2 U Filter and…Sims Deltec, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K933390Remote Reservoir Adapter (TM) Cassette with BagPharmacia Deltec, Inc.19941
0 (this device)K991301Cadd-Prizm High Volume Administration Set with 1.2 U Filter and Add-on…Sims Deltec, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
FIG. 1 — Lineage of K991301, 1994–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K943310Model 6100 Ambulatory Infusion System
Summary page 2
…lve Add-on Anti-siphon Valve | Add-on Anti-siphon Valve MANUFACTURER SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. 510(K) NUMBER Subject Device K943310 Subject Device K933390 K954870 INDICATIONS FOR The CADD-Prizm® High | The CADD-Prizm® High The CADD® The CADD® USE Volume Adminis…
Pharmacia Deltec, Inc.1995—
*K933390Remote Reservoir Adapter (TM) Cassette with Bag
Summary page 2
…Valve | Add-on Anti-siphon Valve MANUFACTURER SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. 510(K) NUMBER Subject Device K943310 Subject Device K933390 K954870 INDICATIONS FOR The CADD-Prizm® High | The CADD-Prizm® High The CADD® The CADD® USE Volume Administration Set | Volume Ad…
Pharmacia Deltec, Inc.19941
*K954870Sims Deltec Anti-Siphon Valve
Summary page 2
…Add-on Anti-siphon Valve MANUFACTURER SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. SIMS Deltec, Inc. 510(K) NUMBER Subject Device K943310 Subject Device K933390 K954870 INDICATIONS FOR The CADD-Prizm® High | The CADD-Prizm® High The CADD® The CADD® USE Volume Administration Set | Volume Administra…
Sims Deltec, Inc.1995—

Also cleared against K943310: 1 other device →

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

DateClassRecallRoot causeReason
Dec 9, 2011Not classifiedZ-0775-2012Mixed-up of materials/componentsSmith Medical has become aware of a small number of customer reports regarding occlusions/high pressure alarms with the use of one lot of CADD High Volume Administration Sets. EXPANDED: Smiths Medical became aware that an additional…

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.
  • 1 other device also cites its predicate K943310.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPA

11in 2025

2007: 162008: 182009: 102010: 232011: 122012: 212013: 132014: 222015: 172016: 122017: 172018: 42019: 72020: 102021: 132022: 142023: 142024: 72025: 112026 (partial year): 5
2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007: 75 days median2008: 89 days median2009: 166 days median2010: 120 days median2011: 87 days median2012: 96 days median2013: 90 days median2014: 89 days median2015: 123 days median2016: 195 days median2017: 240 days median2018: 177 days median2019: 161 days median2020: 327 days median2021: 186 days median2022: 213 days median2023: 340 days median2024: 244 days median2025: 225 days median2026 (partial year): 266 days median
2007high 340 (2023) · low 75 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FPA

98in 2025

2007: 172008: 152009: 1662010: 582011: 282012: 16, 4 Class I2013: 642014: 242015: 62016: 102017: 132018: 42019: 132020: 1072021: 12022: 9, 5 Class I2023: 12, 4 Class I2024: 13, 1 Class I2025: 98, 1 Class I2026 (partial year): 10, 2 Class I
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

2007: 1,4992008: 1,9412009: 2,5122010: 2,5372011: 4,4072012: 4,9302013: 4,6512014: 4,6952015: 6,6252016: 8,4702017: 6,4622018: 6,5742019: 11,2272020: 9,5632021: 10,4142022: 13,3932023: 10,9162024: 47,2102025: 34,506
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071675171,499
20081889151,941
2009101661662,512
201023120582,537
20111287284,407
2012219616 (4)4,930
20131390644,651
20142289244,695
20151712366,625
201612195108,470
201717240136,462
2018417746,574
201971611311,227
2020103271079,563
202113186110,414
2022142139 (5)13,393
20231434012 (4)10,916
2024724413 (1)47,210
20251122598 (1)34,506
2026526610 (2)—

What is it indicated for?

The CADD-Prizm® High Volume Administration Set is designed for use with the CADD-Prizm® pump to allow fluid delivery from an IV bag.

The CADD® Administration Set is designed to be used with a variety of CADD® pumps to allow fluid delivery 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.

Also cleared against K943310

1 other device cites the same predicate.

  • K991599Cadd Administration SetSims Deltec, Inc. · 199932 recalls

More from Sims Deltec, Inc.

32 FDA decisions under this applicant name. See the company

  • K010426Proport Plastic Venous Implantable Access Systems Pre-Assembled with Silicone CatheterSims Deltec, Inc. · 2001
  • K000842Cadd-Prizm PCS II Model 6101 Ambulatory Infusion SystemSims Deltec, Inc. · 20002 recalls
  • K000942Cadd Checkvalve Administration Set, Model 21-7090Sims Deltec, Inc. · 2000
  • K994216Plastic Port Implantable Venous Access SystemSims Deltec, Inc. · 20006 Class I recalls
  • K992697Port-a-Cath II Trans-Arterial Percutaneous SystemSims Deltec, Inc. · 1999

Recent decisions in FPA

The FPA category page

  • K260261Gravity Blood Sets with 200µm FilterB.Braun Medical, Inc. · 2026
  • K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2026
  • K261530iiSure Infusion SetDeka Research and Development · 2026
  • K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF…Amsino International, Inc. · 2026
  • K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc. · 2026

https://510kreport.com/device/K991301 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991301: Cadd-Prizm High Volume Administration Set with 1.2 U Filter and Add-on Anti-Siphon Valve, Cadd Administration Set with 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991301

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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