510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608

K982541510(k) TraditionalCleared Oct 28, 199899-day reviewClass II21 CFR 880.5570Recalls 1

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

Becton Dickinson Vacutainer Systems · FMI Needle, Hypodermic, Single Lumen

Cleared on Oct 28, 1998 as substantially equivalent to K972404 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1997) after a 99-day review. Its family tree reaches back 1 generation to 1997. 25 later devices descend from it. It has been recalled once.

Decided
Oct 28, 1998
Review
99 days
Class
Class II
Product code
FMI
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K972404 (1997). 25 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2023: 4 descendants cleared2021: 4 descendants cleared2003: 1 descendant cleared2016: 1 descendant cleared2019: 1 descendant cleared2018: 4 descendants cleared2007: 1 descendant cleared2010: 1 descendant cleared2020: 1 descendant cleared2024: 1 descendant cleared2012: 1 descendant cleared2022: 3 descendants cleared2025: 1 descendant cleared2026: 1 descendant clearedK972404 · Vacutainer Brand Safety Blood Collection Assembly (Multiple) · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1997 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 8 descendants2 generations forward: 6 descendants3 generations forward: 9 descendants4 generations forward: 2 descendants K972404 · Vacutainer Brand Safety Blood Collection Assembly (Multiple) · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1997 · recalled0
  1. Root · 1 generation backK972404 Vacutainer Brand Safety Blood Collection Assembly (Multiple)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1997 · Recalled
  2. This deviceK982541 Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 &…Becton Dickinson Vacutainer Systems · 1998
  3. Descendant · cites it directly · 13 of its ownK172763 Blood Collecting Needle, Safety Blood Collecting Needle, Blood…Zhejiang Kindly Medical Devices Co., Ltd. · 2018
  4. Descendant · 2 generations on · 6 of its ownK200027 Blood Collection Needle with/without Holder, Safety Blood Collection…Jiangsu Caina Medical Co.,Ltd · 2020
  5. Descendant · cites it directly · 5 of its ownK033478 Vacuette Quickshield Safety Tube HolderGreiner Bio-One Vacuette North America · 2003
  6. Descendant · 2 generations on · 2 of its ownK102774 Vacuette Quickshield with Snappy Tude HolderGreiner Bio-One North America, Inc. · 2010 · Recalled
  7. Descendant · 2 generations on · 1 of its ownK230080 Blood Collection Set, Blood Collection Set with Holder, Safety Blood…Yangzhou Medline Industry, Co., Ltd. · 2023

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2003: 12007: 12010: 12012: 12016: 12018: 42019: 12020: 12021: 42022: 32023: 42024: 12025: 12026: 1
2003high 4 (2018) · low 0 (2004)2026

Most influential descendants

Showing 5 of 25 · See all
  • K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with…Zhejiang Kindly Medical Devices Co., Ltd. · 2018 · cites it directly13descendants
  • K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without…Jiangsu Caina Medical Co.,Ltd · 2020 · 2 generations on6descendants
  • K033478Vacuette Quickshield Safety Tube HolderGreiner Bio-One Vacuette North America · 2003 · cites it directly5descendants
  • K102774Vacuette Quickshield with Snappy Tude HolderGreiner Bio-One North America, Inc. · 2010 · 2 generations on2descendants
  • K230080Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set…Yangzhou Medline Industry, Co., Ltd. · 2023 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K972404Vacutainer Brand Safety Blood Collection Assembly (Multiple)Bd Becton Dickinson Vacutainer Systems Preanalytic19971
0 (this device)K982541Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608Becton Dickinson Vacutainer Systems1998—
+1K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting…Zhejiang Kindly Medical Devices Co., Ltd.2018—
+2K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle…Jiangsu Caina Medical Co.,Ltd2020—
+1K033478Vacuette Quickshield Safety Tube HolderGreiner Bio-One Vacuette North America2003—
+2K102774Vacuette Quickshield with Snappy Tude HolderGreiner Bio-One North America, Inc.20101
+2K230080Blood Collection Set, Blood Collection Set with Holder, Safety Blood…Yangzhou Medline Industry, Co., Ltd.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200710
201010
201210
201610
201840
201910
202010
202140
202230
202340
202410
202510
202610
FIG. 1 — Lineage of K982541, 1997–2026Source: 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? (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
*K972404Vacutainer Brand Safety Blood Collection Assembly (Multiple)
Summary page 3
…te Device K-Number Clearance Date Becton Dickinson VACUTAINER® Brand N/A Pre-amendment VACUTAINER® Blood Collection Needle Systems Becton Dickinson VACUTAINER® Brand | K972404 July 22, 1997. VACUTAINER® Safety Blood Collection Systems Assembly _dma thenecer, RIEPRLS Andrea Hroncich Date Regulatory Aff…
Bd Becton Dickinson Vacutainer Systems Preanalytic19971
*—VACUTAINER® Brand VACUTAINER® Blood Collection Needle
Named without a submission number
—

Also cleared against K972404: 1 other device →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with…Zhejiang Kindly Medical Devices Co., Ltd.201813
K033478Vacuette Quickshield Safety Tube HolderGreiner Bio-One Vacuette North America20035
K223854Unistik® ShieldLock, Unistik VacuFlipOwen Mumford, Ltd.20230
K200932Blood Collection NeedlesVacutest Kima Srl20210
K202325EasyPoint Blood Collection PlusRetractable Technologies, Inc.20210
K181730BD Vacutainer Eclipse UltraFill Blood Collection NeedleBecton, Dickinson and Company20190
K170824BD Vacutainer Eclipse Signal Blood Collection NeedleBecton, Dickinson and Company20180
K153388IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection…Guangzhou Improve Medical Instruments Co., Ltd.20160

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 7, 2019Class IIZ-0252-2020Nonconforming Material/ComponentBD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K172763 (Zhejiang Kindly Medical Devices Co., Ltd., 2018) has gone furthest, with 13 descendants of its own.
  • 1 other device also cites its predicate K972404.

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 VACUTAINER® Brand ECLIPSE™ Blood Collection Needle is a sterile, multiple sample, single-use device for blood collection. The needle is designed with an attached safety shield, which can be activated to cover the needle immediately after venipuncture to provide protection from accidental needle sticks.

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 K972404

1 other device cites the same predicate.

  • K021475BD Single Lumen Needle, Syringe and Blood Collection SetBd · 20023 recalls

More from Becton Dickinson Vacutainer Systems

15 FDA decisions under this applicant name. See the company

  • K002456Microtainer Brand Sodium Fluoride/Edta Tube with Microgard Closure, Model 365992Becton Dickinson Vacutainer Systems · 200010 recalls
  • K991702Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965, 365985, 365963, 365967, 36578Becton Dickinson Vacutainer Systems · 19999 recalls
  • K991088Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok Blood Collection, Safety…Becton Dickinson Vacutainer Systems · 19994 recalls
  • K991120Vacutainer Brand Ctad Tube (Multiple)Becton Dickinson Vacutainer Systems · 1999
  • K982922Vacutainer Brand Blood Collection SyringeBecton Dickinson Vacutainer Systems · 1998

Recent decisions in FMI

The FMI category page

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https://510kreport.com/device/K982541 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982541: Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982541

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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