510(k) Report

510(k) · Cleared

Cleared

B-D Interlink Syringe Cannula

K920422510(k) TraditionalCleared Apr 29, 199289-day reviewClass II21 CFR 880.5860

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 · FMF Syringe, Piston

Cleared on Apr 29, 1992 after an 89-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.

Decided
Apr 29, 1992
Review
89 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
0

6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 2 descendants cleared2017: 1 descendant cleared2011: 1 descendant cleared2012: 1 descendant cleared2020: 1 descendant cleared1990200020102020
  1. This deviceK920422 B-D Interlink Syringe CannulaBd Becton Dickinson Vacutainer Systems Preanalytic · 1992
  2. Descendant · cites it directly · 4 of its ownK974006 Becton Dickinson TwinpakBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
  3. Descendant · 2 generations on · 1 of its ownK170900 DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +…Intervene Group, Ltd. · 2017
  4. Descendant · 2 generations on · 1 of its ownK102328 Blunt Fill Needle and Blunt Plastic CannulaShandong Weigao Group Medical Polymer Co., Ltd. · 2011
  5. Descendant · 3 generations on · 0 of its ownK201031 NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc. · 2020
  6. Descendant · 3 generations on · 0 of its ownK120420 Sterile Blunt for Single UseShanghai Double Dove Industrial Co., Ltd. · 2012

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1998: 22011: 12012: 12017: 12020: 1
1998high 2 (1998) · low 0 (1999)2026

Most influential descendants

Showing 5 of 6 · See all
  • K974006Becton Dickinson TwinpakBd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · cites it directly4descendants
  • K170900DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6…Intervene Group, Ltd. · 2017 · 2 generations on1descendant
  • K102328Blunt Fill Needle and Blunt Plastic CannulaShandong Weigao Group Medical Polymer Co., Ltd. · 2011 · 2 generations on1descendant
  • K201031NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc. · 2020 · 3 generations on0descendants
  • K120420Sterile Blunt for Single UseShanghai Double Dove Industrial Co., Ltd. · 2012 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920422B-D Interlink Syringe CannulaBd Becton Dickinson Vacutainer Systems Preanalytic1992—
+1K974006Becton Dickinson TwinpakBd Becton Dickinson Vacutainer Systems Preanalytic1998—
+2K170900DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +…Intervene Group, Ltd.2017—
+2K102328Blunt Fill Needle and Blunt Plastic CannulaShandong Weigao Group Medical Polymer Co., Ltd.2011—
+3K201031NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc.2020—
+3K120420Sterile Blunt for Single UseShanghai Double Dove Industrial Co., Ltd.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
201110
201210
201710
202010
FIG. 1 — Lineage of K920422, 1992–2020Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FMF? 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 FMF device

  1. #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K974006Becton Dickinson TwinpakBd Becton Dickinson Vacutainer Systems Preanalytic19984
K971924Blunt Syringe CannulaB.Braun Medical, Inc.19980

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, K974006 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1998) has gone furthest, with 4 descendants of its own.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMF

13in 2025

2007: 232008: 92009: 142010: 112011: 162012: 92013: 122014: 132015: 112016: 122017: 132018: 82019: 112020: 152021: 202022: 242023: 222024: 142025: 132026 (partial year): 9
2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007: 90 days median2008: 74 days median2009: 94 days median2010: 130 days median2011: 109 days median2012: 86 days median2013: 154 days median2014: 84 days median2015: 87 days median2016: 146 days median2017: 135 days median2018: 87 days median2019: 146 days median2020: 107 days median2021: 175 days median2022: 211 days median2023: 173 days median2024: 130 days median2025: 114 days median2026 (partial year): 239 days median
2007high 239 (2026) · low 74 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMF

19in 2023

2007: 62008: 112009: 152010: 122011: 32012: 62013: 12014: 12015: 22017: 32018: 22019: 12020: 22021: 12022: 22023: 19, 18 Class I2026 (partial year): 2, 1 Class I
2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007: 6742008: 6912009: 9132010: 6792011: 1862012: 3072013: 3262014: 2442015: 2732016: 6842017: 1,8582018: 3,9522019: 5,8632020: 5,3342021: 5,8742022: 5,2332023: 5,2142024: 5,1222025: 4,181
2007high 5,874 (2021) · low 186 (2011)2025

MAUDE reports naming product code FMF, 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
200723906674
200897411691
2009149415913
20101113012679
2011161093186
20129866307
2013121541326
201413841244
201511872273
2016121460684
20171313531,858
201888723,952
20191114615,863
20201510725,334
20212017515,874
20222421125,233
20232217319 (18)5,214
20241413005,122
20251311404,181
202692392 (1)—
Cite this page

510(k) Report. “K920422: B-D Interlink Syringe Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920422

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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