510(k) · Cleared

Cleared

Punctur-Guard Revolution Holder, Model 4750

K992091510(k) TraditionalCleared Sep 9, 199980-day reviewClass II21 CFR 880.5570

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

Bio-Plexus, Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on Sep 9, 1999 as substantially equivalent to K963748 (Bio-Plexus, Inc., 1997) after an 80-day review. Its family tree reaches back 1 generation to 1997.

Decided: Sep 9, 1999
Review: 80 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K963748 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK963748 Bio-Plexus Drop-IT Needle HolderBio-Plexus, Inc. · 1997
This deviceK992091 Punctur-Guard Revolution Holder, Model 4750Bio-Plexus, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K963748	Bio-Plexus Drop-IT Needle Holder	Bio-Plexus, Inc.	1997	—
0 (this device)	K992091	Punctur-Guard Revolution Holder, Model 4750	Bio-Plexus, Inc.	1999	—

FIG. 1 — Lineage of K992091, 1997–1999Source: 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 FMI? 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 FMI device

#1 K252886 Pen Needlescore 14.5 · 4 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
*	K963748	Bio-Plexus Drop-IT Needle Holder Summary page 1 …Needle Holder Class I Performance Standard Not listed in 21 CFR 860 - 897 10.3 Predicate Device Trade Name DROP-IT® Needle Holder Company Bio-Plexus, Inc. 510(k) Number K963748 Marketing Approval Received June 6, 1997 10.4 Description The REVOLUTION Holder is designed to hold PUNCTUR-GUARD® Blood Collect…	Bio-Plexus, Inc.	1997	—

Also cleared against K963748: 1 other device →

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?

Its one ancestor has no recall.
1 other device also cites its predicate K963748.

How does its category compare?

All FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMI

11in 2025

2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007high 263 (2020) · low 71 (2007)2026

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

Recalls per year · FMI

1in 2024

2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007high 4,986 (2023) · low 177 (2008)2025

MAUDE reports naming product code FMI, 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	15	71	2	208
2008	10	85	4	177
2009	7	177	3	263
2010	15	119	79	249
2011	12	113	5	240
2012	17	107	1	215
2013	11	87	1	255
2014	14	155	3	287
2015	10	89	1	567
2016	20	217	0	941
2017	9	253	16	1,547
2018	20	176	0	2,398
2019	12	186	5	4,896
2020	11	263	3	4,245
2021	18	143	7	4,532
2022	23	189	0	4,885
2023	18	112	2	4,986
2024	3	90	1	4,053
2025	11	141	0	2,424
2026	12	119	1 (1)	—

What is it indicated for?

The REVOLUTION Holder is used in blood drawing procedures. It is used with PUNCTUR-GUARD® Blood Collection Needles only, and is compatible with standard blood sample tubes as well as pediatric inserts.

The REVOLUTION Holder should be used by health care workers experienced in phlebotomy.

At the end of a blood draw, the holder dial is rotated clockwise 90°. This rotation activates the safety mechanism of the PUNCTUR-GUARD® needle, which reduces the probability of an accidental needle stick.

The needle can be eliminated quickly by a push on the release button. The holder is re-usable for up to 100 draws, including 20 cleanings.

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/K992091 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992091: Punctur-Guard Revolution Holder, Model 4750.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992091

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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