510(k) Report

510(k) · Cleared

Recalled · 2003

Butterfly Non-Coring Needle Set

K863606510(k) TraditionalCleared Dec 18, 198693-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

Cormed, Inc., Sub. C.R.Bard, Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on Dec 18, 1986 after a 93-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 71 later devices descend from it. It has been recalled once.

Decided
Dec 18, 1986
Review
93 days
Class
Class II
Product code
FMI
Recalls
1
Predicates
0

71 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2002: 1 descendant cleared2004: 1 descendant cleared2005: 1 descendant cleared2006: 1 descendant cleared2007: 11 descendants cleared2019: 2 descendants cleared2008: 7 descendants cleared2009: 2 descendants cleared2011: 5 descendants cleared2010: 2 descendants cleared2025: 6 descendants cleared2023: 3 descendants cleared2024: 2 descendants cleared2014: 3 descendants cleared2013: 6 descendants cleared2012: 3 descendants cleared2016: 1 descendant cleared2017: 4 descendants cleared2015: 2 descendants cleared2020: 2 descendants cleared2021: 3 descendants cleared2026: 2 descendants cleared1990200020102020
  1. This deviceK863606 Butterfly Non-Coring Needle SetCormed, Inc., Sub. C.R.Bard, Inc. · 1986
  2. Descendant · cites it directly · 70 of its ownK013394 Liftloc Safety Infusion SetSpecialized Health Products, Inc. · 2001 · Recalled
  3. Descendant · 2 generations on · 68 of its ownK042234 Modification to: Liftloc Saftey Infusion SetSpecialty Health Products, Inc. · 2004
  4. Descendant · 2 generations on · 67 of its ownK050600 Miniloc Safety Infusion SetSpecialized Health Products, Intl. · 2005 · Recalled
  5. Descendant · 3 generations on · 66 of its ownK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
  6. Descendant · 4 generations on · 20 of its ownK070003 Power Injectable Implantable Infusion Port with Silicone Lumen…Medcomp · 2007 · Recalled

Showing 5 of 71 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12004: 12005: 12006: 12007: 112008: 72009: 22010: 22011: 52012: 32013: 62014: 32015: 22016: 12017: 42019: 22020: 22021: 32023: 32024: 22025: 62026: 2
2001high 11 (2007) · low 0 (2003)2026

Most influential descendants

Showing 5 of 71 · See all
  • K013394Liftloc Safety Infusion SetSpecialized Health Products, Inc. · 2001 · cites it directly70descendants
  • K042234Modification to: Liftloc Saftey Infusion SetSpecialty Health Products, Inc. · 2004 · 2 generations on68descendants
  • K050600Miniloc Safety Infusion SetSpecialized Health Products, Intl. · 2005 · 2 generations on67descendants
  • K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc. · 2006 · 3 generations on66descendants
  • K070003Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…Medcomp · 2007 · 4 generations on20descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K863606Butterfly Non-Coring Needle SetCormed, Inc., Sub. C.R.Bard, Inc.1986—
+1K013394Liftloc Safety Infusion SetSpecialized Health Products, Inc.20011
+2K042234Modification to: Liftloc Saftey Infusion SetSpecialty Health Products, Inc.2004—
+2K050600Miniloc Safety Infusion SetSpecialized Health Products, Intl.20052
+3K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.20061
+4K070003Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…Medcomp20073

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200410
200510
200610
2007110
200870
200920
201020
201150
201230
201360
201430
201520
201610
201740
201920
202020
202130
202330
202420
202560
202620
FIG. 1 — Lineage of K863606, 1986–2026Source: 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), 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
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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? (71)

See all 71

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013394Liftloc Safety Infusion SetSpecialized Health Products, Inc.200170

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 23, 2003Not classifiedZ-0098-04OtherSterility of product is compromised by open seals in packaging.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K013394 (Specialized Health Products, Inc., 2001) has gone furthest, with 70 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 Cormed, Inc., Sub. C.R.Bard, Inc.

8 FDA decisions under this applicant name. See the company

  • K860432Percutaneous Introducer KitCormed, Inc., Sub. C.R.Bard, Inc. · 1986
  • K854019Port-GardCormed, Inc., Sub. C.R.Bard, Inc. · 1985
  • K850967Sterile Cormed MediportCormed, Inc., Sub. C.R.Bard, Inc. · 1985
  • K850674Cormed II Ambulatory Infusion PumpCormed, Inc., Sub. C.R.Bard, Inc. · 1985
  • K843083Cormed Huber Point NeedleCormed, Inc., Sub. C.R.Bard, Inc. · 1984

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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/K863606 · printed Nov 4, 2026

Cite this page

510(k) Report. “K863606: Butterfly Non-Coring Needle Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K863606

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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