510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Anesthesia Kit, Epidural, Single Shot

K770356510(k) TraditionalCleared Mar 1, 19777-day reviewClass II21 CFR 868.5140Recalls 8

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

Arrow Intl., Inc. · CAZ Anesthesia Conduction Kit

Cleared on Mar 1, 1977 after a 7-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 8 times.

Decided
Mar 1, 1977
Review
7 days
Class
Class II
Product code
CAZ
Recalls
8
Predicates
0

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

FIG. 1 — Lineage of K770356Source: FDA 510(k) database · 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?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Jul 6, 2020Class IIZ-2801-2020Incorrect or no expiration dateThe lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility…
Oct 29, 2010Not classifiedZ-1351-2011OtherSterility may be compromised.
Oct 29, 2010Not classifiedZ-1352-2011OtherSterility may be compromised.
Oct 29, 2010Not classifiedZ-1361-2011OtherSterility may be compromised.
Oct 29, 2010Not classifiedZ-1353-2011OtherSterility may be compromised.
Oct 29, 2010Not classifiedZ-1343-2011OtherSterility may be compromised.
Oct 29, 2010Not classifiedZ-1350-2011OtherSterility may be compromised.
Oct 29, 2010Not classifiedZ-1354-2011OtherSterility may be compromised.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I 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

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)—

More from Arrow Intl., Inc.

110 FDA decisions under this applicant name. See the company

  • K100635Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model: S-44041-002…Arrow Intl., Inc. · 2010
  • K093050Arrow Seldinger Arterial Catherization Devices, Models EX Sac 00520Arrow Intl., Inc. · 2009
  • K071491Arrow International, Inc., Surgical DrapesArrow Intl., Inc. · 2007
  • K071998Arrow Echogenic Introducer Needle ComponentArrow Intl., Inc. · 20072 recalls
  • K071111Non-Absorbable Silk SutureArrow Intl., Inc. · 2007

Recent decisions in CAZ

The CAZ category page

  • K261372Profoject™ LOR SyringeCMT Health PTE., Ltd. · 2026
  • K222341Arrow 0.2 Micron Flat Filter, GVSArrow International, LLC · 2023
  • K210983BD Epilor SyringeBecton, Dickinson and Company · 2022
  • K201356Plastic LOR SyringeJiangsu Caina Medical Co.,Ltd · 2021
  • K202699E-Cath STIM acc. TsuiPAJUNK GmbH Medizintechnologie · 2020

https://510kreport.com/device/K770356 · printed Nov 3, 2026

Cite this page

510(k) Report. “K770356: Anesthesia Kit, Epidural, Single Shot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K770356

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