510(k) Report

510(k) · Cleared

Cleared

Mediziv Epidural Systems

K894725510(k) TraditionalCleared Oct 13, 198980-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

Mediziv Medical Devices, Ltd. · CAZ Anesthesia Conduction Kit

Cleared on Oct 13, 1989 after an 80-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
Oct 13, 1989
Review
80 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 1997: 1 descendant cleared1990200020102020
  1. This deviceK894725 Mediziv Epidural SystemsMediziv Medical Devices, Ltd. · 1989
  2. Descendant · cites it directly · 0 of its ownK964783 Epidural Mini Kit, Eldor Combined Spinal/Epidural KitAlexander Medical, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K964783Epidural Mini Kit, Eldor Combined Spinal/Epidural KitAlexander Medical, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K894725Mediziv Epidural SystemsMediziv Medical Devices, Ltd.1989—
+1K964783Epidural Mini Kit, Eldor Combined Spinal/Epidural KitAlexander Medical, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K894725, 1989–1997Source: 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
Get a 510(k) Report

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
K964783Epidural Mini Kit, Eldor Combined Spinal/Epidural KitAlexander Medical, Inc.19970

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, K964783 (Alexander Medical, Inc., 1997) 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)—

More from Mediziv Medical Devices, Ltd.

2 FDA decisions under this applicant name. See the company

  • K884491Mediziv Central Vein CatheterMediziv Medical Devices, Ltd. · 1989

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/K894725 · printed Nov 4, 2026

Cite this page

510(k) Report. “K894725: Mediziv Epidural Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K894725

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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