510(k) · Cleared

Recalled · Class I · 2024

Cadd Medication Cassette Reservoir

K081156510(k) TraditionalCleared Jul 18, 200886-day reviewClass II21 CFR 880.5440Recalls 10 (1 Class I)

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

Smiths Medical MD, Inc. · FPA Set, Administration, Intravascular

Cleared on Jul 18, 2008 as substantially equivalent to K040636 (Smiths Medical MD, Inc., 2004) after an 86-day review. Its family tree reaches back 1 generation to 2004. 3 of the 4 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 10 times, including a Class I recall.

Decided: Jul 18, 2008
Review: 86 days
Class: Class II
Product code: FPA
Recalls: 10 (1 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to K040636 (2004). 2 later devices descend from it, 1 citing it directly. 3 of the 4 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK040636 Cadd Administration Set with Flow Stop, Medication Cassette…Smiths Medical MD, Inc. · 2004 · Recalled (Class I)
This deviceK081156 Cadd Medication Cassette ReservoirSmiths Medical MD, Inc. · 2008
Descendant · cites it directly · 1 of its ownK162219 CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · Recalled (Class I)
Descendant · 2 generations on · 0 of its ownK211649 PCEA Syringe SetBaxter Healthcare Corporation · 2021

Class I recalls in this family

K040636 Cadd Administration Set with Flow Stop…direct predicate · 2004
K162219 CADD® Infusion Disposables Portfolio with NRFit™…cites it directly · 2017

Most influential descendants

Showing 2 of 2 · See all

K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · cites it directly1descendant
K211649PCEA Syringe SetBaxter Healthcare Corporation · 2021 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K040636	Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with…	Smiths Medical MD, Inc.	2004	Class I
0 (this device)	K081156	Cadd Medication Cassette Reservoir	Smiths Medical MD, Inc.	2008	—
+1	K162219	CADD® Infusion Disposables Portfolio with NRFit™ connectors	Smiths Medical Asd, Inc.	2017	Class I
+2	K211649	PCEA Syringe Set	Baxter Healthcare Corporation	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	1
2021	1	0

FIG. 1 — Lineage of K081156, 2004–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

3 devices in this family have a Class I recall. 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K040636	Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and… Summary page 1 …and intended use to the predecessor CADD Medication Cassette T Reservoir with Flow Stop, K040636. These sets are identical except for size and Page 1 of 2…	Smiths Medical MD, Inc.	2004	Class I
*	—	Flexible Medication Reservoir Named without a submission number			—

Also cleared against K040636: 2 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K162219	CADD® Infusion Disposables Portfolio with NRFit™ connectors Class I	Smiths Medical Asd, Inc.	2017	1

Has anything in its family been recalled? (3 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 26, 2024	Class II	Z-0010-2025	Process control	Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Jun 26, 2024	Class II	Z-0011-2025	Process control	Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Jun 26, 2024	Class II	Z-0013-2025	Process control	Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Jun 26, 2024	Class II	Z-0017-2025	Process control	Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Jun 26, 2024	Class II	Z-0018-2025	Process control	Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Jun 26, 2024	Class II	Z-0012-2025	Process control	Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Jun 26, 2024	Class II	Z-0014-2025	Process control	Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Jun 26, 2024	Class II	Z-0015-2025	Process control	Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Jun 26, 2024	Class II	Z-0016-2025	Process control	Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Dec 9, 2022	Class I	Z-0964-2023	Under Investigation by firm	There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

The 5 latest of 10 recalls; the web page lists all.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K040636Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and Extension SetSmiths Medical MD, Inc. · 2004 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has a recall, Class I.
Of its descendants, K162219 (Smiths Medical Asd, Inc., 2017) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K040636.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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 CADD™ Medication Cassette reservoirs are intended for the delivery of medications and fluids for subcutaneous, intramuscular, intravenous, intra-arterial, intraperitoneal, or intraspinal infusion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081156 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081156: Cadd Medication Cassette Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081156

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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