510(k) Report

510(k) · Cleared

Cleared

Punctur-Guard (TM) Blood Collection Needle

K895024510(k) TraditionalCleared Sep 21, 1990409-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 21, 1990 after a 409-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.

Decided
Sep 21, 1990
Review
409 days
Class
Class II
Product code
FMI
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 2 descendants cleared1997: 1 descendant cleared2004: 1 descendant cleared2002: 1 descendant cleared2007: 1 descendant cleared2018: 1 descendant cleared2021: 1 descendant cleared1990200020102020
  1. This deviceK895024 Punctur-Guard (TM) Blood Collection NeedleBio-Plexus, Inc. · 1990
  2. Descendant · cites it directly · 3 of its ownK043258 Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Teleflex Medical · 2004
  3. Descendant · 2 generations on · 1 of its ownK070449 Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc. · 2007
  4. Descendant · 2 generations on · 0 of its ownK211072 Safety Trocar CannulaBoston Scientific Corporation · 2021
  5. Descendant · 2 generations on · 0 of its ownK180725 Aspire Introducer NeedleAspire Bariatrics, Inc. · 2018
  6. Descendant · cites it directly · 0 of its ownK020985 Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2002

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

1997: 11998: 22002: 12004: 12007: 12018: 12021: 1
1997high 2 (1998) · low 0 (1999)2026

Most influential descendants

Showing 5 of 8 · See all
  • K043258Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Teleflex Medical · 2004 · cites it directly3descendants
  • K070449Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc. · 2007 · 2 generations on1descendant
  • K211072Safety Trocar CannulaBoston Scientific Corporation · 2021 · 2 generations on0descendants
  • K180725Aspire Introducer NeedleAspire Bariatrics, Inc. · 2018 · 2 generations on0descendants
  • K020985Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K895024Punctur-Guard (TM) Blood Collection NeedleBio-Plexus, Inc.1990—
+1K043258Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Teleflex Medical2004—
+2K070449Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc.2007—
+2K211072Safety Trocar CannulaBoston Scientific Corporation2021—
+2K180725Aspire Introducer NeedleAspire Bariatrics, Inc.2018—
+1K020985Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199820
200210
200410
200710
201810
202110
FIG. 1 — Lineage of K895024, 1990–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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. #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K043258Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Teleflex Medical20043
K020985Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc.20020
K982797Blunt T-Peel Introducer Model Number PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICBLuther Medical Products, Inc.19980
K971077Covertip Safety SyringeMedisys Technologies, Inc.19980
K973012MDC Safe Step Safety Blood Collection Needle SystemMDC Research, Ltd.19970

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, K043258 (Teleflex Medical, 2004) has gone furthest, with 3 descendants of its own.

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

2007: 152008: 102009: 72010: 152011: 122012: 172013: 112014: 142015: 102016: 202017: 92018: 202019: 122020: 112021: 182022: 232023: 182024: 32025: 112026 (partial year): 12
2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007: 71 days median2008: 85 days median2009: 177 days median2010: 119 days median2011: 113 days median2012: 107 days median2013: 87 days median2014: 155 days median2015: 89 days median2016: 217 days median2017: 253 days median2018: 176 days median2019: 186 days median2020: 263 days median2021: 143 days median2022: 189 days median2023: 112 days median2024: 90 days median2025: 141 days median2026 (partial year): 119 days median
2007high 263 (2020) · low 71 (2007)2026

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

Recalls per year · FMI

1in 2024

2007: 22008: 42009: 32010: 792011: 52012: 12013: 12014: 32015: 12017: 162019: 52020: 32021: 72023: 22024: 12026 (partial year): 1, 1 Class I
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

2007: 2082008: 1772009: 2632010: 2492011: 2402012: 2152013: 2552014: 2872015: 5672016: 9412017: 1,5472018: 2,3982019: 4,8962020: 4,2452021: 4,5322022: 4,8852023: 4,9862024: 4,0532025: 2,424
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200715712208
200810854177
200971773263
20101511979249
2011121135240
2012171071215
201311871255
2014141553287
201510891567
2016202170941
20179253161,547
20182017602,398
20191218654,896
20201126334,245
20211814374,532
20222318904,885
20231811224,986
202439014,053
20251114102,424
2026121191 (1)—

More from Bio-Plexus, Inc.

6 FDA decisions under this applicant name. See the company

  • K003827Punctur-Guard Winged Set for Blood CollectionBio-Plexus, Inc. · 2001
  • K992091Punctur-Guard Revolution Holder, Model 4750Bio-Plexus, Inc. · 1999
  • K963748Bio-Plexus Drop-IT Needle HolderBio-Plexus, Inc. · 1997
  • K960933Bio-Plexus Needle Disposal ContainerBio-Plexus, Inc. · 1996
  • K961251Punctur-Guard Winged SetBio-Plexus, Inc. · 1996

Recent decisions in FMI

The FMI category page

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  • K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd. · 2026

https://510kreport.com/device/K895024 · printed Nov 4, 2026

Cite this page

510(k) Report. “K895024: Punctur-Guard (TM) Blood Collection Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K895024

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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