510(k) · Decided
Recalled · Class II · 2025Regional Anesthesia Trays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Industries Medical Systems, Inc. · CAZ Anesthesia Conduction Kit
Cleared on Mar 14, 1997 after an 88-day review. The FDA summary names its predicate without a number. 1 of the 8 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it. It has been recalled 7 times.
- Decided
- Mar 14, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- 7
- Predicates
- 0
7 later devices descend from it, 2 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- This deviceK965017 Regional Anesthesia TraysSmiths Industries Medical Systems, Inc. · 1997
- Descendant · cites it directly · 6 of its ownK092657 Epifuse Catheter Connector, Model: 4909ESmiths Medical Asd, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK110053 Correctinject Safety System, Catheter Connector, Filter, Infusion…Smiths Medical Asd, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK170900 DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +…Intervene Group, Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK162219 CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK211649 PCEA Syringe SetBaxter Healthcare Corporation · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K162219 CADD® Infusion Disposables Portfolio with NRFit™…2 generations on · 2017
Most influential descendants
Showing 5 of 7 · See all- K092657Epifuse Catheter Connector, Model: 4909ESmiths Medical Asd, Inc. · 2009 · cites it directly6descendants
- K110053Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe KitSmiths Medical Asd, Inc. · 2012 · cites it directly5descendants
- K170900DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6…Intervene Group, Ltd. · 2017 · 2 generations on1descendant
- K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · 2 generations on1descendant
- K211649PCEA Syringe SetBaxter Healthcare Corporation · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K965017 | Regional Anesthesia Trays | Smiths Industries Medical Systems, Inc. | 1997 | — |
| +1 | 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 | — |
| +2 | K170900 | DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +… | Intervene Group, Ltd. | 2017 | — |
| +2 | K162219 | CADD® Infusion Disposables Portfolio with NRFit™ connectors | Smiths Medical Asd, Inc. | 2017 | Class I |
| +3 | K211649 | PCEA Syringe Set | Baxter Healthcare Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 2 | 1 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 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.
1 device in this family has 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 CAZ device
- #1 K261372 Profoject™ LOR Syringescore 12.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (13)
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 |
|---|---|---|---|
| * | — | Continuous Epidural Tray, without Drugs, Full Kits Named without a submission number | |
| * | — | Continuous Epidural Tray, with Drugs, Full Kits Named without a submission number | |
| * | — | Continuous Epidural Tray, without Drugs, Mini-Pack Named without a submission number | |
| * | — | Single Shot Epidural Tray, without Drugs Named without a submission number | |
| * | — | Single Shot Epidural Tray, with Drugs Named without a submission number | |
| * | — | B-D Whitacre Spinal Trays, without Drugs Named without a submission number | |
| * | — | B-D Whitacre Spinal Trays, with Drugs Named without a submission number | |
| * | — | B-D Quincke Spinal Trays, with Drugs Named without a submission number | |
| * | — | Pediatric Continuous Epidural/Caudal Systems Named without a submission number | |
| * | — | Pediatric Single Shot Epidural/Caudal Systems Named without a submission number | |
| * | — | Combined Epidural/Spinal Trays, without Drugs Named without a submission number | |
| * | — | Combined Epidural/Spinal Trays, with Drugs Named without a submission number | |
| * | — | Catheter Connector Named without a submission number |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2025 | Class II | Z-1101-2026 | Under Investigation by firm | Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery. |
| Oct 27, 2006 | Not classified | Z-0211-2007 | Other | Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch |
| Nov 17, 2005 | Not classified | Z-0242-06 | Other | Tray may contain holes compromising the sterility of the device |
| Nov 17, 2005 | Not classified | Z-0243-06 | Other | Tray may contain holes compromising the sterility of the device |
| Nov 17, 2005 | Not classified | Z-0244-06 | Other | Tray may contain holes compromising the sterility of the device |
| Nov 17, 2005 | Not classified | Z-0245-06 | Other | Tray may contain holes compromising the sterility of the device |
| Oct 10, 2003 | Not classified | Z-0166-04 | Other | Spinal trays labeled as containing a Whitacre 25g x 3.5' needle actually contain a Quincke 25g x 3.5' needle. |
The 5 latest of 7 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.
- K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K092657 (Smiths Medical Asd, Inc., 2009) has gone furthest, with 6 descendants of its own.
How does its category compare?
All CAZ devicesCAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CAZ
108in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAZ
1in 2024
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · CAZ
137in 2025
MAUDE reports naming product code CAZ, 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 | 4 | 172 | 0 | 81 |
| 2008 | 4 | 99 | 0 | 80 |
| 2009 | 2 | — | 29 | 134 |
| 2010 | 2 | — | 8 | 139 |
| 2011 | 1 | — | 2 | 187 |
| 2012 | 9 | 108 | 0 | 187 |
| 2013 | 0 | — | 12 | 276 |
| 2014 | 0 | — | 2 | 251 |
| 2015 | 1 | — | 1 | 235 |
| 2016 | 2 | — | 1 | 372 |
| 2017 | 0 | — | 0 | 353 |
| 2018 | 0 | — | 0 | 448 |
| 2019 | 1 | — | 0 | 472 |
| 2020 | 1 | — | 0 | 274 |
| 2021 | 1 | — | 0 | 165 |
| 2022 | 1 | — | 0 | 270 |
| 2023 | 1 | — | 0 | 60 |
| 2024 | 0 | — | 1 | 165 |
| 2025 | 0 | — | 0 | 137 |
| 2026 | 1 | — | 12 (11) | — |
What is it indicated for?
SIMS’ Regional Anesthesia Trays are used to administer to a patient regional or local anesthesia.
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/K965017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K965017: Regional Anesthesia Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965017
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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