510(k) · Cleared

Cleared

Sterile Equipment Covers

K931417510(k) TraditionalCleared Jul 6, 1995836-day reviewClass II21 CFR 878.4370

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

Custom Medical Products, Ltd. · MMP Cover, Barrier, Protective

Cleared on Jul 6, 1995 after an 836-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 15 later devices descend from it.

Decided: Jul 6, 1995
Review: 836 days
Class: Class II
Product code: MMP
Recalls: None
Predicates: 0

15 later devices descend from it, 5 citing it directly.

This deviceK931417 Sterile Equipment CoversCustom Medical Products, Ltd. · 1995
Descendant · cites it directly · 9 of its ownK050322 Microtek Equipment DrapesMicrotek Medical, Inc. · 2005 · Recalled
Descendant · cites it directly · 5 of its ownK961699 Equipment CoversUnited States Surgical, A Division of Tyco Healthc · 1996
Descendant · 2 generations on · 2 of its ownK112782 Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011
Descendant · 2 generations on · 1 of its ownK081476 Surgical Concept Designs Positionor Surgical DrapeSurgical Concept Designs · 2008
Descendant · 2 generations on · 1 of its ownK052395 Sterile Equipment CoversVolcano Corporation · 2005 · Recalled

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

1996high 2 (2002) · low 0 (1997)2026

Most influential descendants

Showing 5 of 15 · See all

K050322Microtek Equipment DrapesMicrotek Medical, Inc. · 2005 · cites it directly9descendants
K961699Equipment CoversUnited States Surgical, A Division of Tyco Healthc · 1996 · cites it directly5descendants
K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011 · 2 generations on2descendants
K081476Surgical Concept Designs Positionor Surgical DrapeSurgical Concept Designs · 2008 · 2 generations on1descendant
K052395Sterile Equipment CoversVolcano Corporation · 2005 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K931417	Sterile Equipment Covers	Custom Medical Products, Ltd.	1995	—
+1	K050322	Microtek Equipment Drapes	Microtek Medical, Inc.	2005	17
+1	K961699	Equipment Covers	United States Surgical, A Division of Tyco Healthc	1996	—
+2	K112782	Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories	Misonix, Inc.	2011	—
+2	K081476	Surgical Concept Designs Positionor Surgical Drape	Surgical Concept Designs	2008	—
+2	K052395	Sterile Equipment Covers	Volcano Corporation	2005	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2002	2	0
2003	1	0
2004	1	0
2005	2	0
2006	1	0
2008	1	0
2009	1	0
2011	1	0
2013	2	0
2014	2	0

FIG. 1 — Lineage of K931417, 1995–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 MMP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (15)

See all 15

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K050322	Microtek Equipment Drapes	Microtek Medical, Inc.	2005	9
K961699	Equipment Covers	United States Surgical, A Division of Tyco Healthc	1996	5
K023540	Snap Kover, Model 01-2020; Snap Kaps, Model 03-KP09	Valumed	2003	1
K014239	Medsurg Equipment Covers	International Medsurg Connection	2002	1
K052668	OR Specific Big Case Back Table Cover	Or Specific, Inc.	2006	0

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, K050322 (Microtek Medical, Inc., 2005) has gone furthest, with 9 descendants of its own.

How does its category compare?

All MMP devices

MMP Cover, Barrier, Protective: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MMP

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MMP

Too few MMP 510(k)s in any year since 2007 to give a median.

Recalls per year · MMP

1in 2011

2007high 5 (2008) · low 0 (2007)2026

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

Adverse event reports per year · MMP

1in 2025

2007high 4 (2019) · low 0 (2007)2025

MAUDE reports naming product code MMP, 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	0	—	0	0
2008	0	—	5	0
2009	1	—	0	0
2010	0	—	0	1
2011	0	—	1	1
2012	0	—	0	0
2013	0	—	0	1
2014	0	—	0	1
2015	0	—	0	3
2016	0	—	0	1
2017	0	—	0	0
2018	0	—	0	1
2019	0	—	0	4
2020	0	—	0	0
2021	0	—	0	1
2022	0	—	0	1
2023	0	—	0	1
2024	0	—	0	1
2025	0	—	0	1
2026	0	—	0	—

https://510kreport.com/device/K931417 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931417: Sterile Equipment Covers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931417

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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