510(k) Report

510(k) · Cleared

Cleared

IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle

K153388510(k) TraditionalCleared Jun 7, 2016197-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

Guangzhou Improve Medical Instruments Co., Ltd. · FMI Needle, Hypodermic, Single Lumen

Cleared on Jun 7, 2016 as substantially equivalent to K980414 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1998) and 2 other predicates after a 197-day review. Its family tree reaches back 3 generations to 1986.

Decided
Jun 7, 2016
Review
197 days
Class
Class II
Product code
FMI
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K861152 (1986). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 2 other ancestors1997: 2 other ancestorsK861152 · Exel Vacuum Blood Collecting System · Exel Intl. · 1986K992699 · Nipro Blood Collection Needle · Nipro Medical Corp. · 2000K090426 · Vaku-8 Blood Collection Needles · Myco Medical Supplies, Inc. · 20091985199019952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors K090426 · Vaku-8 Blood Collection Needles · Myco Medical Supplies, Inc. · 2009K992699 · Nipro Blood Collection Needle · Nipro Medical Corp. · 2000K861152 · Exel Vacuum Blood Collecting System · Exel Intl. · 19860
  1. Root · 3 generations backK861152 Exel Vacuum Blood Collecting SystemExel Intl. · 1986
  2. 2 generations backK992699 Nipro Blood Collection NeedleNipro Medical Corp. · 2000
  3. 1 generation backK090426 Vaku-8 Blood Collection NeedlesMyco Medical Supplies, Inc. · 2009
  4. This deviceK153388 IMPROSAFE Blood Collection Set with Pre-attached Holder…Guangzhou Improve Medical Instruments Co., Ltd. · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K861152Exel Vacuum Blood Collecting SystemExel Intl.1986—
−2K992699Nipro Blood Collection NeedleNipro Medical Corp.2000—
−1K090426Vaku-8 Blood Collection NeedlesMyco Medical Supplies, Inc.2009—
0 (this device)K153388IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood…Guangzhou Improve Medical Instruments Co., Ltd.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199720
199820
FIG. 1 — Lineage of K153388, 1986–2016Source: 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
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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
*K980414Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood…
Summary page 11
…3. Identification of Predicate Devices Proposed Device Predicate Device IMPROSAFE® Blood Collection Set 510(k) Number: K980414 with Pre-attached holder Product Name: VACUTAINER® Brand Blood Collection…
Bd Becton Dickinson Vacutainer Systems Preanalytic19981
*K982541Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608
Summary page 11
…d Blood Collection Set and Safety-LokTM Blood Collection Set IMPROSAFE® Multi Sample Needle 510(k) Number: K982541 Product Name: VACUTAINER® Brand ECLIPSETM Blood…
Becton Dickinson Vacutainer Systems19981
*K090426Vaku-8 Blood Collection Needles
Summary page 11
…t Name: VACUTAINER® Brand ECLIPSETM Blood Collection Needle IMPROVACUTER® Multi Sample 510(k) Number: K090426 Needle Product Name: VAKU-8TM Blood Collection Needle 4. Indications for Use The IM…
Myco Medical Supplies, Inc.2009—

Also cleared against K980414: 11 other devices →

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?

  • The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 9.3 years on median.
  • 3 of the 7 ancestors have a recall of any class.
  • 11 other devices also cite its predicate K980414.

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. 2016, this device’s year, is highlighted.

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 IMPROSAFE® Blood Collection Sets with Pre-attached holder are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The IMPROSAFE® Multi-Sample Needles are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against…

Read the full statement (209 words)

The IMPROSAFE® Blood Collection Sets with Pre-attached holder are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The IMPROSAFE® Multi-Sample Needles are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The IMPROVACUTER® Blood Collection Sets are intended to be used with evacuated blood collection tube for the collection of venous blood.

The IMPROSAFE® Blood Collection Sets are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The IMPROVACUTER® Blood Collection Sets with Pre-attached holder are intended to be used with evacuated blood collection tube for the collection of venous blood.

The IMPROSAFE® Multi-Sample Needles (Flashback) are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The IMPROVACUTER® Multi-Sample Needles are used with holder and vacuum blood collection tube for the venous blood collection.

Indications for use as stated in the FDA summary.

Also cleared against K980414

11 other devices cite the same predicate.

  • K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with…Becton, Dickinson and Company · 2026
  • K232781Safety Sliding Blood Collection SetJiangsu Caina Medical Co.,Ltd · 2024
  • K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached HolderSol-Millennium Medical, Inc. · 2017
  • K162233Kurin Blood Culture Collection SetPathway, LLC · 2016
  • K102994K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorKawasumi Laboratories, Inc. · 2010
  • K102890K-Shield Small Vein Infusion / Winged Collection Set W/ Anti Needle Stick Protector (and Multisample Luer…Kawasumi Laboratories America, Inc. · 2010

More from Guangzhou Improve Medical Instruments…

2 FDA decisions under this applicant name. See the company

  • K093910Improvacuter Gel & Clot Activator TubeGuangzhou Improve Medical Instruments Co., Ltd. · 2010

Recent decisions in FMI

The FMI category page

  • K261266MOWANA™ Auto DuoPentamaster Mediq SDN BHD · 2026
  • K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2026
  • K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety…Hh Global Technology, Inc. · 2026
  • 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/K153388 · printed Nov 6, 2026

Cite this page

510(k) Report. “K153388: IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153388

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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