510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Vacuette Safety Blood Collection Set

K011786510(k) TraditionalCleared Jul 12, 200134-day reviewClass II21 CFR 880.5570Recalls 2

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

Greiner Vacuette North America, Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on Jul 12, 2001 as substantially equivalent to K912563 (Mbo Laboratories, Inc., 1991) after a 34-day review. Its family tree reaches back 1 generation to 1991. 10 later devices descend from it. It has been recalled 2 times.

Decided
Jul 12, 2001
Review
34 days
Class
Class II
Product code
FMI
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K912563 (1991). 10 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2012: 1 descendant cleared2010: 1 descendant cleared2019: 1 descendant cleared2018: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant cleared2023: 1 descendant clearedK912563 · Angel Wing Safety Blood Collection and Infusion SE · Mbo Laboratories, Inc. · 19911990200020102020
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants K912563 · Angel Wing Safety Blood Collection and Infusion SE · Mbo Laboratories, Inc. · 19910
  1. Root · 1 generation backK912563 Angel Wing Safety Blood Collection and Infusion SEMbo Laboratories, Inc. · 1991
  2. This deviceK011786 Vacuette Safety Blood Collection SetGreiner Vacuette North America, Inc. · 2001
  3. Descendant · cites it directly · 7 of its ownK080235 Safety Infusion SetGreiner Bio-One Vacuette North America · 2008
  4. Descendant · cites it directly · 6 of its ownK121908 Safety Infusion SetGreiner Bio-One North America, Inc. · 2012
  5. Descendant · 2 generations on · 2 of its ownK173757 VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetGreiner Bio-One Na, Inc. · 2018
  6. Descendant · 2 generations on · 2 of its ownK170276 Safety Blood Collection Device for Single UseGemtier Medical (Shanghai), Inc. · 2017
  7. Descendant · 3 generations on · 1 of its ownK214075 Safety Blood Collection / Infusion Set (with/without needle holder)…Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2022

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2008: 12010: 12012: 12017: 12018: 12019: 12021: 12022: 12023: 12025: 1
2008high 1 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 10 · See all
  • K080235Safety Infusion SetGreiner Bio-One Vacuette North America · 2008 · cites it directly7descendants
  • K121908Safety Infusion SetGreiner Bio-One North America, Inc. · 2012 · cites it directly6descendants
  • K173757VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetGreiner Bio-One Na, Inc. · 2018 · 2 generations on2descendants
  • K170276Safety Blood Collection Device for Single UseGemtier Medical (Shanghai), Inc. · 2017 · 2 generations on2descendants
  • K214075Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection /…Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2022 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K912563Angel Wing Safety Blood Collection and Infusion SEMbo Laboratories, Inc.1991—
0 (this device)K011786Vacuette Safety Blood Collection SetGreiner Vacuette North America, Inc.2001—
+1K080235Safety Infusion SetGreiner Bio-One Vacuette North America2008—
+1K121908Safety Infusion SetGreiner Bio-One North America, Inc.2012—
+2K173757VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetGreiner Bio-One Na, Inc.2018—
+2K170276Safety Blood Collection Device for Single UseGemtier Medical (Shanghai), Inc.2017—
+3K214075Safety Blood Collection / Infusion Set (with/without needle holder), Blood…Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201210
201710
201810
201910
202110
202210
202310
202510
FIG. 1 — Lineage of K011786, 1991–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
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Get a 510(k) Report

What was it cleared against? (2)

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
*K912563Angel Wing Safety Blood Collection and Infusion SE
Summary page 1
…ssification Name: Catheter, Intravascular, Short-Term Vacuette® Safety Blood Collection Set PREDICATE DEVICE: Sherwood Medical Angel Wing™ Safety Blood Collection Set (K912563) DEVICE DESCRIPTION: INTENDED USE: The VACUETTE® Safety Blood Collection Set is a single-use, sterile, winged blood collection…
Mbo Laboratories, Inc.1991—
*—Monoject® Angel Wing Blood Collection Set
Named without a submission number
—

Also cleared against K912563: 2 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K080235Safety Infusion SetGreiner Bio-One Vacuette North America20087
K121908Safety Infusion SetGreiner Bio-One North America, Inc.20126
K102010Vacuette Premium Safety Blood Collection SetMedpro Safety Products, Inc.20101

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 1, 2013Class IIZ-0835-2013OtherThe VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
Mar 10, 2003Not classifiedZ-0797-03OtherThe needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K080235 (Greiner Bio-One Vacuette North America, 2008) has gone furthest, with 7 descendants of its own.
  • 2 other devices also cite its predicate K912563.

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?

The VACUETTE® Safety Blood Collection Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a female luer adapter. The VACUETTE® Safety Blood Collection Set is used in routine venipuncture procedures. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.

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 K912563

2 other devices cite the same predicate.

  • K131950Angel Tip Safety Intravascular Needle SetSummit International Medical Technologies, Inc. · 2015
  • K993848Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc. · 20002 recalls

More from Greiner Vacuette North America, Inc.

5 FDA decisions under this applicant name. See the company

  • K014104Vacuette Edta K2 TubesGreiner Vacuette North America, Inc. · 2002
  • K012043Vacuette Edta K2 Gel TubesGreiner Vacuette North America, Inc. · 2001
  • K003812Vacuette Speedy Quick-Release HolderGreiner Vacuette North America, Inc. · 2001
  • K002777Vacuette with PpackGreiner Vacuette North America, Inc. · 2000

Recent decisions in FMI

The FMI category page

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  • K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R…Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2026
  • K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd. · 2026

https://510kreport.com/device/K011786 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011786: Vacuette Safety Blood Collection Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011786

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026