510(k) · Cleared

Recalled · Class III · 2017

Kiltex Probe Cover

K961029510(k) TraditionalCleared Jul 25, 1996133-day reviewClass II21 CFR 892.1560Recalls 2

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

Kiltex Corp. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Jul 25, 1996 as substantially equivalent to K895614 (CIVCO Medical Instruments Co., Inc., 1989) after a 133-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it. It has been recalled 2 times.

Decided: Jul 25, 1996
Review: 133 days
Class: Class II
Product code: IYO
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K895614 (1989). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK895614 Civco Latex Ultrasound SheathsCIVCO Medical Instruments Co., Inc. · 1989
This deviceK961029 Kiltex Probe CoverKiltex Corp. · 1996
Descendant · cites it directly · 0 of its ownK974301 CLK Int'l. Sanitary Latex Probe Cover, CLK Ultrasound Probe CoverClk Intl., Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all

K974301CLK Int'l. Sanitary Latex Probe Cover, CLK Ultrasound Probe CoverClk Intl., Inc. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K895614	Civco Latex Ultrasound Sheaths	CIVCO Medical Instruments Co., Inc.	1989	—
0 (this device)	K961029	Kiltex Probe Cover	Kiltex Corp.	1996	—
+1	K974301	CLK Int'l. Sanitary Latex Probe Cover, CLK Ultrasound Probe Cover	Clk Intl., Inc.	1998	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K961029, 1989–1998Source: 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 IYO? 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 IYO device

#1 K243937 Accuro 3Sscore 20.5 · 18 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? (1)

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
*	K895614	Civco Latex Ultrasound Sheaths Summary page 1 …equipment as used by Carter-Wallace. In August 1992, CIVCO Medical Instruments Co., Inc. contracted with Kiltex Corporation to manufacture under their (CIVCO's) 510(K) #K895614 natural latex prophylactics to be sold and used solely as ultrasound probe covers. These probe covers are identical to those form…	CIVCO Medical Instruments Co., Inc.	1989	—

Also cleared against K895614: 3 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K974301	CLK Int'l. Sanitary Latex Probe Cover, CLK Ultrasound Probe Cover	Clk Intl., Inc.	1998	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 22, 2017	Class III	Z-2332-2018	Labeling False and Misleading	The incorrect IFU was shipped with the product.
Nov 22, 2017	Class III	Z-2333-2018	Labeling False and Misleading	The incorrect IFU was shipped with the product.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K974301 (Clk Intl., Inc., 1998) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K895614.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYO

7in 2025

2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007high 220 (2024) · low 17 (2007)2026

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

Recalls per year · IYO

1in 2022

2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, 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	20	17	4	39
2008	14	36	5	20
2009	13	79	9	27
2010	15	113	8	20
2011	11	69	0	58
2012	15	68	2	78
2013	17	50	3	436
2014	14	63	2	304
2015	19	46	1	268
2016	10	36	0	254
2017	19	72	0	238
2018	14	56	1	368
2019	13	59	1	537
2020	11	57	0	498
2021	15	64	11	617
2022	5	190	1	511
2023	11	177	0	527
2024	10	220	0	640
2025	7	171	0	485
2026	10	139	1	—

https://510kreport.com/device/K961029 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961029: Kiltex Probe Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961029

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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