510(k) Report

510(k) · Cleared

Cleared

Auto-Fill Syringe Kit, Model 7600

K063851510(k) TraditionalCleared Jan 26, 200729-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

Vascular Solutions, Inc. · FMF Syringe, Piston

Cleared on Jan 26, 2007 as substantially equivalent to K033721 (Vascular Solutions, Inc., 2004) and 3 other predicates after a 29-day review. Its family tree reaches back 1 generation to 1979. 1 later device descends from it.

Decided
Jan 26, 2007
Review
29 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K792227 (1979). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1992: 1 other ancestor1985: 1 other ancestor2013: 1 descendant clearedK792227 · Multi-AD Fluid Dispensing System · National Patent Development Corp. · 197919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant K792227 · Multi-AD Fluid Dispensing System · National Patent Development Corp. · 19790
  1. Root · 1 generation backK792227 Multi-AD Fluid Dispensing SystemNational Patent Development Corp. · 1979
  2. This deviceK063851 Auto-Fill Syringe Kit, Model 7600Vascular Solutions, Inc. · 2007
  3. Descendant · cites it directly · 0 of its ownK131661 Infusion Syringe SetInnovative Medical Manufacturing Co. · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K131661Infusion Syringe SetInnovative Medical Manufacturing Co. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K792227Multi-AD Fluid Dispensing SystemNational Patent Development Corp.1979—
0 (this device)K063851Auto-Fill Syringe Kit, Model 7600Vascular Solutions, Inc.2007—
+1K131661Infusion Syringe SetInnovative Medical Manufacturing Co.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199210
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K063851, 1979–2013Source: 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 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
Get a 510(k) Report

What was it cleared against? (5)

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
*K033721Vascular Solutions Auto-Fill Syringe Kit
Summary page 2
…this product have been developed under Section 514 of the Act. Predicate Device(s) * Auto-FillTM Syringe Kit marketed by Vascular Solutions, Inc. (K033721) * IV Administration Set marketed by DeRoyal® (Codan USA) (pre-amendment device) * Angiographic Control S…
Vascular Solutions, Inc.2004—
*K920135Medroyal Angiographic Control Syringe
Summary page 2
…* IV Administration Set marketed by DeRoyal® (Codan USA) (pre-amendment device) * Angiographic Control Syringe, marketed by DeRoyal, Inc. (CDI) (K920135) · L.O.N. Pressure Monitoring Lines, CPC Lines, Administration, marketed by DeRoyal (CDI) (K853099) * Mult…
Medroyal, Inc.1992—
*K853099L.O.N. Pres Mon Lines, CPC Lines, Administration
Summary page 2
…hic Control Syringe, marketed by DeRoyal, Inc. (CDI) (K920135) · L.O.N. Pressure Monitoring Lines, CPC Lines, Administration, marketed by DeRoyal (CDI) (K853099) * Multi-Ad Fluid Dispensing System, marketed by B. Braun Medical, K792227 Device Description The Auto-Fill Syringe…
L.O.N. Research, Inc.1985—
*K792227Multi-AD Fluid Dispensing System
Summary page 2
…essure Monitoring Lines, CPC Lines, Administration, marketed by DeRoyal (CDI) (K853099) * Multi-Ad Fluid Dispensing System, marketed by B. Braun Medical, K792227 Device Description The Auto-Fill Syringe Kit contains disposable components that may be used to deliver dilute lid…
National Patent Development Corp.1979—
*—IV Administration Set
Named without a submission number
—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K131661Infusion Syringe SetInnovative Medical Manufacturing Co.20130

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K131661 (Innovative Medical Manufacturing Co., 2013) has gone furthest, with 0 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. 2007, this device’s year, is highlighted.

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)—

What is it indicated for?

The Auto-Fill® Syringe Kit is indicated for the introduction of dilute lidocaine solutions into subcutaneous tissues for the purposes of tumescent local anesthesia.

Indications for use as stated in the FDA summary.

More from Vascular Solutions, Inc.

135 FDA decisions under this applicant name. See the company

  • P990037/S036Duett Sealing Device (D-Stat Flowable)Vascular Solutions, Inc. · 2022
  • P990037/S035Duett Sealing DeviceVascular Solutions, Inc. · 2021
  • K182232Octane Mechanical Thrombectomy SystemVascular Solutions, Inc. · 2018
  • K181647Bandit guidewireVascular Solutions, Inc. · 2018
  • K180913VSI Micro-Introducer KitVascular Solutions, Inc. · 2018

Recent decisions in FMF

The FMF category page

  • K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC · 2026
  • K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc. · 2026
  • K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd. · 2026
  • K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC · 2026
  • K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026

https://510kreport.com/device/K063851 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063851: Auto-Fill Syringe Kit, Model 7600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063851

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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