510(k) Report

510(k) · Cleared

Cleared

B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16

K002938510(k) TraditionalCleared Nov 29, 200069-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

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

Cleared on Nov 29, 2000 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 121 later devices descend from it.

Decided
Nov 29, 2000
Review
69 days
Class
Class II
Product code
FMI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 2 descendants cleared2007: 4 descendants cleared2010: 3 descendants cleared2002: 1 descendant cleared2017: 6 descendants cleared2025: 9 descendants cleared2016: 6 descendants cleared2014: 5 descendants cleared2012: 2 descendants cleared2011: 4 descendants cleared2013: 4 descendants cleared2026: 5 descendants cleared2008: 1 descendant cleared2009: 1 descendant cleared2022: 16 descendants cleared2020: 7 descendants cleared2023: 18 descendants cleared2018: 3 descendants cleared2015: 2 descendants cleared2021: 13 descendants cleared2019: 3 descendants cleared2024: 6 descendants cleared200020052010201520202025
  1. This deviceK002938 B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16Bd Becton Dickinson Vacutainer Systems Preanalytic · 2000
  2. Descendant · cites it directly · 100 of its ownK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
  3. Descendant · 2 generations on · 91 of its ownK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
  4. Descendant · 3 generations on · 78 of its ownK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
  5. Descendant · 4 generations on · 36 of its ownK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
  6. Descendant · 3 generations on · 31 of its ownK112057 KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011

Showing 5 of 121 descendants. See all descendants

Descendants cleared per year

2002: 12005: 22007: 42008: 12009: 12010: 32011: 42012: 22013: 42014: 52015: 22016: 62017: 62018: 32019: 32020: 72021: 132022: 162023: 182024: 62025: 92026: 5
2002high 18 (2023) · low 0 (2003)2026

Most influential descendants

Showing 5 of 121 · See all
  • K021475BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · cites it directly100descendants
  • K070440BD Hypoint NeedleBecton, Dickinson & CO · 2007 · 2 generations on91descendants
  • K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008 · 3 generations on78descendants
  • K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011 · 4 generations on36descendants
  • K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011 · 3 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002938B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16Bd Becton Dickinson Vacutainer Systems Preanalytic2000—
+1K021475BD Single Lumen Needle, Syringe and Blood Collection SetBd20023
+2K070440BD Hypoint NeedleBecton, Dickinson & CO2007—
+3K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd.2008—
+4K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd.2011—
+3K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co.,2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200520
200740
200810
200910
201030
201140
201220
201340
201450
201520
201660
201760
201830
201930
202070
2021130
2022160
2023180
202460
202590
202650
FIG. 1 — Lineage of K002938, 2000–2026Source: 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
Get a 510(k) Report

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? (121)

See all 121

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

NumberDeviceApplicantDecidedDescendants
K021475BD Single Lumen Needle, Syringe and Blood Collection SetBd2002100
K052561Terumo Micro Tapered Pen NeedleKofu Factory of Terumo Corp.200517
K100812Ulticare Disposable Pen NeedlesUltimed, Inc.20109
K070988SC Profi Fine Pen Needle, Models; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)Shinchang Medical Co., Ltd.20070
K050464Ultracare Disposable Pen Needles, Models 31 Gauge X3/16, 29 Gauge X 1/2Ultimed, Inc.20050

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, K021475 (Bd, 2002) has gone furthest, with 100 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 Bd Becton Dickinson Vacutainer Systems…

656 FDA decisions under this applicant name. See the company

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  • K003461BD Vacutainer Passive Shielding Blood Collection NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 2001
  • K001364BD Directigen Flu a+BBd Becton Dickinson Vacutainer Systems Preanalytic · 2000
  • K000762Moxifloxacin, 5 UG, BBL Sensi-DiscBd Becton Dickinson Vacutainer Systems Preanalytic · 20001 recall

Recent decisions in FMI

The FMI category page

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https://510kreport.com/device/K002938 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002938: B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002938

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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