510(k) · Cleared
Recalled · Class I · 2026CADD® Infusion Disposables Portfolio with NRFit™ connectors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · PWH Administrations Sets With Neuraxial Connectors
Cleared on Jul 20, 2017 as substantially equivalent to K040636 (Smiths Medical MD, Inc., 2004) and 4 other predicates after a 346-day review. Its family tree reaches back 3 generations to 1997. 3 of the 13 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Jul 20, 2017
- Review
- 346 days
- Class
- Class II
- Product code
- PWH
- Recalls
- 2 (1 Class I)
- Predicates
- 5
Its longest line of descent runs back 3 generations to K965017 (1997). 11 ancestors in all, the oldest K801343 (1980). 1 later device descends from it, 1 citing it directly. 3 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK965017 Regional Anesthesia TraysSmiths Industries Medical Systems, Inc. · 1997 · Recalled
- 2 generations backK092657 Epifuse Catheter Connector, Model: 4909ESmiths Medical Asd, Inc. · 2009
- 1 generation backK110053 Correctinject Safety System, Catheter Connector, Filter, Infusion…Smiths Medical Asd, Inc. · 2012
- This deviceK162219 CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK211649 PCEA Syringe SetBaxter Healthcare Corporation · 2021
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K211649PCEA Syringe SetBaxter Healthcare Corporation · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K965017 | Regional Anesthesia Trays | Smiths Industries Medical Systems, Inc. | 1997 | 7 |
| −2 | K092657 | Epifuse Catheter Connector, Model: 4909E | Smiths Medical Asd, Inc. | 2009 | — |
| −1 | K110053 | Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor… | Smiths Medical Asd, Inc. | 2012 | — |
| 0 (this device) | K162219 | CADD® Infusion Disposables Portfolio with NRFit™ connectors | Smiths Medical Asd, Inc. | 2017 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 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.
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
- #2 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K040636 | Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and…Summary page 6…II II Product Code FPA FPA 510(k) K162219 K040636 (100ml), K081156 (250ml) Subject Device Predicate Device Trade Name CA… | 2004 |
| * | K081156 | Cadd Medication Cassette ReservoirSummary page 6…II Product Code FPA FPA 510(k) K162219 K040636 (100ml), K081156 (250ml) Subject Device Predicate Device Trade Name CADD Filling Adapte… | 2008 |
| * | K110053 | Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe KitSummary page 6…II II Product Code LHI CAZ 510(k) K162219 K110053 Page 1 of 12 510(k) S… | 2012 |
| * | K942046 | Pharmacia Deltec Extension Set with Anti-Siphon ValveSummary page 7…II Product Code FPA FPA 510(k) K162219 K942046 Subject Device Predicate Device Trade Name CADD Yellow Extension… | 1994 |
| * | K974013 | Extension Set with Microbore Tubing, Extension Set with Microbore Tubing and 0.2 U…Summary page 7…II Product Code FPA FPA 510(k) K162219 K974013 Subject Device Predicate Device Trade Name CADD Yellow Administr… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211649 | PCEA Syringe Set | 2021 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 20, 2026 | Class II | Z-3212-2026 | Process control | Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus. |
| Dec 9, 2022 | Class I | Z-0965-2023 | 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 |
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.
- K081156Cadd Medication Cassette ReservoirSmiths Medical MD, Inc. · 2008 · Direct predicate · ◆ 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 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 5 of the 11 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K211649 (Baxter Healthcare Corporation, 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K040636.
How does its category compare?
All PWH devicesPWH Administrations Sets With Neuraxial Connectors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PWH
1in 2023
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 1 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 17 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
CADD Yellow Medication Cassette Reservoirs with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, and are designed for use with CADD pumps (see CADD pump Operator’s Manual for compatibility) and CADD Yellow Extension Sets with NRFit™ connectors. The CADD Filling Adapter with male NRFit™ connector and female Luer is an accessory for use in filling of the CADD Medication Cassette…
Read the full statement (262 words)
CADD Yellow Medication Cassette Reservoirs with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, and are designed for use with CADD pumps (see CADD pump Operator’s Manual for compatibility) and CADD Yellow Extension Sets with NRFit™ connectors.
The CADD Filling Adapter with male NRFit™ connector and female Luer is an accessory for use in filling of the CADD Medication Cassette Reservoirs with NRFit™ Connector.
CADD Yellow Extension Sets with NRFit™ connectors are designed for use only with CADD Yellow Medication Cassette Reservoirs with NRFit™ connectors for the delivery of regional anesthetics or narcotics.
CADD Yellow Administration Sets with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics and are designed for use with CADD pumps (see CADD pump Operator’s Manual for compatibility).
The Male Yellow Cap with NRFit™ connector is intended for use as an accessory with the CADD Yellow Medication Cassette reservoirs.
The Female Yellow Cap with NRFit™ connector is intended for use as an accessory with the CADD Yellow Extension sets with NRFit™ connectors and the CADD Yellow Administration sets with NRFit™ connector.
The CADD Infusion Adapter with male NRFit™ connector and female Luer is intended to be used by clinicians to convert administration sets with Luer connectors into permanently dedicated lines for use only with NRFit connectors. The NRFit™ connector with non-luer taper is intended for the injection or infusion of regional anesthetics or narcotics and may help reduce the risk of mis-connection or mis-injection.
The Intended population is pediatrics and adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162219: CADD® Infusion Disposables Portfolio with NRFit™ connectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162219
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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