510(k) · Cleared

Cleared

Percuguard

K992539510(k) TraditionalCleared Feb 18, 2000203-day reviewClass I21 CFR 880.6250

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

Cleared on Feb 18, 2000 after a 203-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.

Decided: Feb 18, 2000
Review: 203 days
Class: Class I
Product code: LZB
Recalls: None
Predicates: 0

3 later devices descend from it, 2 citing it directly.

This deviceK992539 PercuguardDigit-Pro · 2000
Descendant · cites it directly · 1 of its ownK012199 DigicapHumana USA, Inc. · 2001
Descendant · cites it directly · 0 of its ownK052387 Arthrex Fingershield Finger Guard, Model AR-7199-XXArthrex, Inc. · 2005
Descendant · 2 generations on · 0 of its ownK042534 Marina Medical Finger ProtectorsMarina Medical Instruments, Inc. · 2005

Most influential descendants

Showing 3 of 3 · See all

K012199DigicapHumana USA, Inc. · 2001 · cites it directly1descendant
K052387Arthrex Fingershield Finger Guard, Model AR-7199-XXArthrex, Inc. · 2005 · cites it directly0descendants
K042534Marina Medical Finger ProtectorsMarina Medical Instruments, Inc. · 2005 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K992539	Percuguard	Digit-Pro	2000	—
+1	K012199	Digicap	Humana USA, Inc.	2001	—
+1	K052387	Arthrex Fingershield Finger Guard, Model AR-7199-XX	Arthrex, Inc.	2005	—
+2	K042534	Marina Medical Finger Protectors	Marina Medical Instruments, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2005	2	0

FIG. 1 — Lineage of K992539, 2000–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LZB? 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K012199	Digicap	Humana USA, Inc.	2001	1
K052387	Arthrex Fingershield Finger Guard, Model AR-7199-XX	Arthrex, Inc.	2005	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, K012199 (Humana USA, Inc., 2001) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LZB devices

LZB Finger Cot: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZB

FDA has decided no LZB device since 2007.

Median 510(k) review, days · LZB

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

Recalls per year · LZB

No recall names LZB since 2007.

Adverse event reports per year · LZB

No MAUDE report names LZB since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

Tte intended use of PERCUGUARD ™ is 1o prevent accidental needie stick and/or sharps injuries to healthcare workers on the fingers and thumbs exposed to injuries.

it & a protective finger guard accessory 1o the examination glove. [tis used on the finger and/ar the thumb of the non-dominant hand usually used to retract, stabiize. or isolate in preparation for an injection procedure. i may be inverted and used to prevent accidental needls sticks while suturing. It can be used on the dorninant hand (device invertad) when isolating, retracting, stabilizing, or paipating tissue where sharp bane or wires are present in order ta protect the palm sids of the fingers o thumbs

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K992539 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992539: Percuguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992539

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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