510(k) · Cleared

Cleared

PCEA Syringe Set

K211649510(k) TraditionalCleared Nov 23, 2021179-day reviewClass II21 CFR 880.5440

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

Baxter Healthcare Corporation · PWH Administrations Sets With Neuraxial Connectors

Cleared on Nov 23, 2021 as substantially equivalent to K162219 (Smiths Medical Asd, Inc., 2017) after a 179-day review. Its family tree reaches back 4 generations to 1997. 3 of the 13 devices in its family, counting itself, have a Class I recall.

Decided: Nov 23, 2021
Review: 179 days
Class: Class II
Product code: PWH
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K965017 (1997). 12 ancestors in all, the oldest K801343 (1980). No later device cites it as a predicate yet. 3 of the 13 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK965017 Regional Anesthesia TraysSmiths Industries Medical Systems, Inc. · 1997 · Recalled
3 generations backK092657 Epifuse Catheter Connector, Model: 4909ESmiths Medical Asd, Inc. · 2009
2 generations backK110053 Correctinject Safety System, Catheter Connector, Filter, Infusion…Smiths Medical Asd, Inc. · 2012
1 generation backK162219 CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · Recalled (Class I)
This deviceK211649 PCEA Syringe SetBaxter Healthcare Corporation · 2021

Class I recalls in this family

K162219 CADD® Infusion Disposables Portfolio with NRFit™…direct predicate · 2017
K081156 Cadd Medication Cassette Reservoir2 generations back · 2008
K040636 Cadd Administration Set with Flow Stop…2 generations back · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K965017	Regional Anesthesia Trays	Smiths Industries Medical Systems, Inc.	1997	7
−3	K092657	Epifuse Catheter Connector, Model: 4909E	Smiths Medical Asd, Inc.	2009	—
−2	K110053	Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor…	Smiths Medical Asd, Inc.	2012	—
−1	K162219	CADD® Infusion Disposables Portfolio with NRFit™ connectors	Smiths Medical Asd, Inc.	2017	Class I
0 (this device)	K211649	PCEA Syringe Set	Baxter Healthcare Corporation	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	1	0
1981	1	0
1994	1	0
1997	1	0
1998	1	0
2004	1	1
2008	1	1
2009	1	0

FIG. 1 — Lineage of K211649, 1997–2021Source: 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 PWH device

#1 K221319 BD Alaris™ Pump Epidural Infusion Setscore 6.0 · 2 generations · no Class I recall

Get a 510(k) 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	Applicant	Decided	Recalls
*	K162219	CADD® Infusion Disposables Portfolio with NRFit™ connectors Summary page 5 …Device Company Predicate 510(k) Date CADD Yellow Extension Sets Smiths Medical ASD, Inc. K162219 July 20, 2017 with NRFit™ connector REASON FOR SUBMISSION: The basis for this premarket notification is the intent…	Smiths Medical Asd, Inc.	2017	Class I

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

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.

K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K081156Cadd Medication Cassette ReservoirSmiths Medical MD, Inc. · 2008 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
K040636Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and Extension SetSmiths Medical MD, Inc. · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
6 of the 12 ancestors have a recall of any class; 3 have a Class I recall.

How does its category compare?

All PWH devices

PWH Administrations Sets With Neuraxial Connectors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · PWH

1in 2023

2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PWH

Too few PWH 510(k)s in any year since 2007 to give a median.

Recalls per year · PWH

No recall names PWH since 2007.

Adverse event reports per year · PWH

8in 2025

2007high 17 (2022) · low 0 (2007)2025

MAUDE reports naming product code PWH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	1	—	0
2018	1	—	0
2019	0	—	0
2020	0	—	5
2021	1	—	5
2022	0	—	17
2023	1	—	2
2024	0	—	16
2025	0	—	8
2026	0	—	—

What is it indicated for?

For the administration of anesthetics and/or analgesics from a syringe into the patient’s epidural space through an epidural access device.

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/K211649 · printed Nov 6, 2026

Cite this page

510(k) Report. “K211649: PCEA Syringe Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211649

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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