510(k) Report

510(k) · Decided

Decided

Sensi-Touch Epidural Anesthesia Tray

K950929510(k) TraditionalDecided May 30, 199590-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 May 30, 1995 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
May 30, 1995
Review
90 days
Class
Class II
Product code
CAZ
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1995200020052010201520202025
  1. This deviceK950929 Sensi-Touch Epidural Anesthesia TraySherwood Medical Co. · 1995
  2. Descendant · cites it directly · 0 of its ownK962880 Sensi-Touch Combo Spinal/Epidural Regional Anesthesia Delivery SystemSherwood Medical Co. · 1996

Most influential descendants

Showing 1 of 1 · See all
  • K962880Sensi-Touch Combo Spinal/Epidural Regional Anesthesia Delivery SystemSherwood Medical Co. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950929Sensi-Touch Epidural Anesthesia TraySherwood Medical Co.1995—
+1K962880Sensi-Touch Combo Spinal/Epidural Regional Anesthesia Delivery SystemSherwood Medical Co.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K950929, 1995–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K261372 Profoject™ LOR Syringescore 12.4 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K962880Sensi-Touch Combo Spinal/Epidural Regional Anesthesia Delivery SystemSherwood Medical Co.19960

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?

  • Of its descendants, K962880 (Sherwood Medical Co., 1996) has gone furthest, with 0 descendants of its own.

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

2007: 42008: 42009: 22010: 22011: 12012: 92015: 12016: 22019: 12020: 12021: 12022: 12023: 12026 (partial year): 1
2007high 9 (2012) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAZ

108in 2012

2007: 172 days median2008: 99 days median2012: 108 days median
2007high 172 (2007) · low 99 (2008)2026

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

Recalls per year · CAZ

1in 2024

2009: 292010: 82011: 22013: 122014: 22015: 12016: 12024: 12026 (partial year): 12, 11 Class I
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

2007: 812008: 802009: 1342010: 1392011: 1872012: 1872013: 2762014: 2512015: 2352016: 3722017: 3532018: 4482019: 4722020: 2742021: 1652022: 2702023: 602024: 1652025: 137
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074172081
2008499080
20092—29134
20102—8139
20111—2187
201291080187
20130—12276
20140—2251
20151—1235
20162—1372
20170—0353
20180—0448
20191—0472
20201—0274
20211—0165
20221—0270
20231—060
20240—1165
20250—0137
20261—12 (11)—
Cite this page

510(k) Report. “K950929: Sensi-Touch Epidural Anesthesia Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950929

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026