510(k) Report

510(k) · Cleared

Cleared

Vacuette Multi-Sample Needle

K973620510(k) TraditionalCleared Dec 17, 199785-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

Greiner Meditech, Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on Dec 17, 1997 as substantially equivalent to K950159 (Gainor Medical U.S.A., Inc., 1995) after an 85-day review. Its family tree reaches back 1 generation to 1995. 7 later devices descend from it.

Decided
Dec 17, 1997
Review
85 days
Class
Class II
Product code
FMI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K950159 (1995). 7 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2007: 3 descendants cleared2006: 1 descendant cleared2011: 2 descendants cleared2024: 1 descendant clearedK950159 · Suresharp · Gainor Medical U.S.A., Inc. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K950159 · Suresharp · Gainor Medical U.S.A., Inc. · 19950
  1. Root · 1 generation backK950159 SuresharpGainor Medical U.S.A., Inc. · 1995
  2. This deviceK973620 Vacuette Multi-Sample NeedleGreiner Meditech, Inc. · 1997
  3. Descendant · cites it directly · 5 of its ownK061483 Vacuette Visio Plus Blood Collection NeedlesGreiner Bio-One North America, Inc. · 2006
  4. Descendant · 2 generations on · 1 of its ownK073127 Blood Collection Needle, Model 20G 21G 22GShandong Weigao Group Medical Polymer Co., Ltd. · 2007
  5. Descendant · cites it directly · 1 of its ownK072320 Greiner Vacuette Quickshield CompleteGreiner Bio-One North America, Inc. · 2007 · Recalled
  6. Descendant · 2 generations on · 0 of its ownK233979 VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc. · 2024
  7. Descendant · 2 generations on · 0 of its ownK110656 Imc Blood Collection NeedleInternational Medsurg Connection · 2011

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2006: 12007: 32011: 22024: 1
2006high 3 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 7 · See all
  • K061483Vacuette Visio Plus Blood Collection NeedlesGreiner Bio-One North America, Inc. · 2006 · cites it directly5descendants
  • K073127Blood Collection Needle, Model 20G 21G 22GShandong Weigao Group Medical Polymer Co., Ltd. · 2007 · 2 generations on1descendant
  • K072320Greiner Vacuette Quickshield CompleteGreiner Bio-One North America, Inc. · 2007 · cites it directly1descendant
  • K233979VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc. · 2024 · 2 generations on0descendants
  • K110656Imc Blood Collection NeedleInternational Medsurg Connection · 2011 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K950159SuresharpGainor Medical U.S.A., Inc.1995—
0 (this device)K973620Vacuette Multi-Sample NeedleGreiner Meditech, Inc.1997—
+1K061483Vacuette Visio Plus Blood Collection NeedlesGreiner Bio-One North America, Inc.2006—
+2K073127Blood Collection Needle, Model 20G 21G 22GShandong Weigao Group Medical Polymer Co., Ltd.2007—
+1K072320Greiner Vacuette Quickshield CompleteGreiner Bio-One North America, Inc.20071
+2K233979VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc.2024—
+2K110656Imc Blood Collection NeedleInternational Medsurg Connection2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200730
201120
202410
FIG. 1 — Lineage of K973620, 1995–2024Source: 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), 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. #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
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K950159Suresharp
Summary page 1
…holder which is used to guide the needle into an evacuated blood collection tube.. Greiner is claiming substantial equivalence to Gainor Medical’s Suresharp” needles (K950159). Both multi-sample needles have the same intended use and contain the same material. The material of the Greiner needle is stain…
Gainor Medical U.S.A., Inc.1995—

Also cleared against K950159: 1 other device →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K061483Vacuette Visio Plus Blood Collection NeedlesGreiner Bio-One North America, Inc.20065
K072320Greiner Vacuette Quickshield CompleteGreiner Bio-One North America, Inc.20071
K071947Vacu-Med Blood Collection NeedlesShina Corp.20070

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.
  • Of its descendants, K061483 (Greiner Bio-One North America, Inc., 2006) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K950159.

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)—

What is it indicated for?

For use in venous blood collection

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K950159

1 other device cites the same predicate.

  • K981619Vacuette Multiple Sample Luer AdapterGreiner Meditech, Inc. · 1998

More from Greiner Meditech, Inc.

10 FDA decisions under this applicant name. See the company

  • K992145Ecomed Scalp Vein SetGreiner Meditech, Inc. · 19991 recall
  • K992244Greiner Minicollect Coagulation Blood Collection TubeGreiner Meditech, Inc. · 1999
  • K991843Greiner Minicollect Lithium Heparin Gel Blood Collection TubeGreiner Meditech, Inc. · 1999
  • K983952Greiner Vacuette Blood Collection TubeGreiner Meditech, Inc. · 19983 recalls
  • K982998Greiner Minicollect Serum Gel Blood Collection TubeGreiner Meditech, Inc. · 1998

Recent decisions in FMI

The FMI category page

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https://510kreport.com/device/K973620 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973620: Vacuette Multi-Sample Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973620

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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