510(k) · Decided

Decided

Sensi-Touch Combo Spinal/Epidural Regional Anesthesia Delivery System

K962880510(k) TraditionalDecided Dec 9, 1996138-day reviewClass II21 CFR 868.5140

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

Sherwood Medical Co. · CAZ Anesthesia Conduction Kit

Cleared on Dec 9, 1996 as substantially equivalent to K950929 (Sherwood Medical Co., 1995) and 2 other predicates after a 138-day review. Its family tree reaches back 1 generation to 1993.

Decided: Dec 9, 1996
Review: 138 days
Class: Class II
Product code: CAZ
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K932249 (1993). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK932249 Durasafe B-D Combined Spinal Epidural AnesthesiaBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
This deviceK962880 Sensi-Touch Combo Spinal/Epidural Regional Anesthesia Delivery SystemSherwood Medical Co. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K932249	Durasafe B-D Combined Spinal Epidural Anesthesia	Bd Becton Dickinson Vacutainer Systems Preanalytic	1993	—
0 (this device)	K962880	Sensi-Touch Combo Spinal/Epidural Regional Anesthesia Delivery System	Sherwood Medical Co.	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1995	1	0

FIG. 1 — Lineage of K962880, 1993–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CAZ? 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

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What was it cleared against? (4)

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
*	K950929	Sensi-Touch Epidural Anesthesia Tray Summary page 1 …egional Anesthesia Delivery System is substantially equivalent to Sherwood Medical'’s currently marketed Sensi-Touch Epidural Anesthesia Delivery System (preamendment & #K950929) and Sensi-Touch Spinal Trays (preamendment) in that they both contain the components commonly required to place an anesthesia ne…	Sherwood Medical Co.	1995	—
*	K932249	Durasafe B-D Combined Spinal Epidural Anesthesia Summary page 1 …ch™ Combo Spinal/Epidural Regional Anesthesia Delivery System is substantially equivalent to the Durasafe Combined Spinal Epidural Sets (cleared via the 510(k) process, #K932249) in that they both have the same intended use and basic components. The Sensi-Touch™ Combo Spinal/Epidural Regional Anesthesia…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1993	—
*	K932400	Espocan Combined Spinal/Epidural Needle Set & Tray Summary page 1 …uch™ Combo Spinal/Epidural Regional Anesthesia Delivery System is substantially equivalent to the Espocan Combined Spinal/Epidural Sets (cleared via the 510(k) process, #K932400) in that they both have the same intended use and basic components.	B. Braun of America, Inc.	1993	—
*	—	Sensi-Touch Spinal Trays Named without a submission number			—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 3 ancestors has a recall.

How does its category compare?

All CAZ devices

CAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAZ

1in 2023

2007high 9 (2012) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAZ

108in 2012

2007high 172 (2007) · low 99 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CAZ

1in 2024

2007high 29 (2009) · low 0 (2007)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · CAZ

137in 2025

2007high 472 (2019) · low 60 (2023)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?

The combo tray is intended for Surgical or OB regional anesthesia blocks.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K962880 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962880: Sensi-Touch Combo Spinal/Epidural Regional Anesthesia Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962880

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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