510(k) · Cleared

Cleared

Epidural Mini Kit, Eldor Combined Spinal/Epidural Kit

K964783510(k) TraditionalCleared Feb 12, 199777-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

Alexander Medical, Inc. · CAZ Anesthesia Conduction Kit

Cleared on Feb 12, 1997 as substantially equivalent to K932614 (Mediziv Medical Products, Ltd., 1994) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1989.

Decided: Feb 12, 1997
Review: 77 days
Class: Class II
Product code: CAZ
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K894725 (1989). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK894725 Mediziv Epidural SystemsMediziv Medical Devices, Ltd. · 1989
This deviceK964783 Epidural Mini Kit, Eldor Combined Spinal/Epidural KitAlexander Medical, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K894725	Mediziv Epidural Systems	Mediziv Medical Devices, Ltd.	1989	—
0 (this device)	K964783	Epidural Mini Kit, Eldor Combined Spinal/Epidural Kit	Alexander Medical, Inc.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

FIG. 1 — Lineage of K964783, 1989–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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.

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What was it cleared against? (3)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K920076	Becton Dickinson Durasafe Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1 …25014), Kendall Safetrak Combined Ep/Sp (K941493), Mediziv Regional Anesthesia Tray (K932614), and Becton Dickinson’s “Durasafe” combined Spinal/Epidural Anesthesia Kit (K920076). The components vary from kit to kit, but the catheter is the same as Becton Dickinson’s Durasafe. Epidural kits have been mar…
*	K932614	Regional Anaesthesia Tray Summary page 1 …livery’s Combined E-Sp (K933711), Preferred Medical’s Epi-Spinal Tray and Miniset (K925014), Kendall Safetrak Combined Ep/Sp (K941493), Mediziv Regional Anesthesia Tray (K932614), and Becton Dickinson’s “Durasafe” combined Spinal/Epidural Anesthesia Kit (K920076). The components vary from kit to kit, but t…	Mediziv Medical Products, Ltd.	1994	—
*	K894725	Mediziv Epidural Systems Summary page 4 …ziv Epidural Set and Combined Spinal/Epidural Kits Durasafe Tray and the Regional Anesthesia Tray 510(k) numbers K920076 K932614 Regional (Combined) NEW- This submission K894725 Epidural Tray Indications for use Same Same Epidural and/or Spinal Anesthesia Warnings / 1) Withdrawing epidural catheter through…	Mediziv Medical Devices, Ltd.	1989	—
†	K932400	Espocan Combined Spinal/Epidural Needle Set & Tray	B. Braun of America, Inc.	1993	—
†	K933711	E-SP Combined Epidural-Spinal Anesthesia Tray	Neurodelivery Technology, Inc.	1993	—
†	K925014	E-SP Combined Epi Spinal Miniset	Neuro Technology	1993	—
†	K941493	Kendall Safetrak Combined Epidural/Spinal Kit	Kendall Healthcare Products Co. Div.Of Tyco Health	1994	—
†	K935235	Endoscopy System for Facial Plastic Surgery	Smith & Nephew Richards, Inc.	1995	—

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 2 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?

Delivery of Epidural anesthesia for the epidural kits and delivery of combined spinal/epidural anesthesia for the combined kits.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K964783 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964783: Epidural Mini Kit, Eldor Combined Spinal/Epidural Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964783

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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