# K965017: Regional Anesthesia Trays

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Industries Medical Systems, Inc.
- Decided: Mar 14, 1997 after 88 days
- Product code: CAZ (Anesthesia Conduction Kit)
- Device class: 2
- Regulation: 21 CFR 868.5140
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Continuous Epidural Tray, without Drugs, Full Kits: named in the summary without a submission number
- (no number) Continuous Epidural Tray, with Drugs, Full Kits: named in the summary without a submission number
- (no number) Continuous Epidural Tray, without Drugs, Mini-Pack: named in the summary without a submission number
- (no number) Single Shot Epidural Tray, without Drugs: named in the summary without a submission number
- (no number) Single Shot Epidural Tray, with Drugs: named in the summary without a submission number
- (no number) B-D Whitacre Spinal Trays, without Drugs: named in the summary without a submission number
- (no number) B-D Whitacre Spinal Trays, with Drugs: named in the summary without a submission number
- (no number) B-D Quincke Spinal Trays, with Drugs: named in the summary without a submission number
- (no number) Pediatric Continuous Epidural/Caudal Systems: named in the summary without a submission number
- (no number) Pediatric Single Shot Epidural/Caudal Systems: named in the summary without a submission number
- (no number) Combined Epidural/Spinal Trays, without Drugs: named in the summary without a submission number
- (no number) Combined Epidural/Spinal Trays, with Drugs: named in the summary without a submission number
- (no number) Catheter Connector: named in the summary without a submission number

## Most influential descendants
- K092657: Epifuse Catheter Connector, Model: 4909E (2009), 6 descendants of its own
- K110053: Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit (2012), 5 descendants of its own
- K170900: DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories (2017), 1 descendant of its own
- K162219: CADD® Infusion Disposables Portfolio with NRFit™ connectors (2017), 1 descendant of its own
- K211649: PCEA Syringe Set (2021), 0 descendants of its own

## Recalls of this device
- Dec 19, 2025 · Class II · Z-1101-2026: 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
- Oct 27, 2006 · Not classified · Z-0211-2007: Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch
- Nov 17, 2005 · Not classified · Z-0242-06: Tray may contain holes compromising the sterility of the device
- Nov 17, 2005 · Not classified · Z-0243-06: Tray may contain holes compromising the sterility of the device
- Nov 17, 2005 · Not classified · Z-0244-06: Tray may contain holes compromising the sterility of the device
- Nov 17, 2005 · Not classified · Z-0245-06: Tray may contain holes compromising the sterility of the device
- Oct 10, 2003 · Not classified · Z-0166-04: Spinal trays labeled as containing a Whitacre 25g x 3.5' needle actually contain a Quincke 25g x 3.5' needle.

## Indications for use
SIMS’ Regional Anesthesia Trays are used to administer to a patient regional or local anesthesia.

Source page: https://510kreport.com/device/K965017
Methodology: https://510kreport.com/methodology