510(k) Report

510(k) · Cleared

Cleared

Drug Access Spike

K051930510(k) TraditionalCleared Aug 16, 200534-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

Medegen Medical Manufacturing Services · FMF Syringe, Piston

Cleared on Aug 16, 2005 as substantially equivalent to K934591 (Icu Medical, Inc., 1994) and 2 other predicates after a 34-day review. Its family tree reaches back 1 generation to 1989.

Decided
Aug 16, 2005
Review
34 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K894177 (1989). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 2 other ancestorsReference device: K011193 · Nac Plus Needleless Access Connector · Porex Medical Products · 2001Reference device: K992268 · Nac PRN Needleless Access Connector · The Kipp Group · 1999K894177 · Needle*Less Drug Vial Adapter · Baxter Healthcare Corp · 198919851990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors K894177 · Needle*Less Drug Vial Adapter · Baxter Healthcare Corp · 19890
  1. Root · 1 generation backK894177 Needle*Less Drug Vial AdapterBaxter Healthcare Corp · 1989
  2. This deviceK051930 Drug Access SpikeMedegen Medical Manufacturing Services · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K894177Needle*Less Drug Vial AdapterBaxter Healthcare Corp1989—
0 (this device)K051930Drug Access SpikeMedegen Medical Manufacturing Services2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
FIG. 1 — Lineage of K051930, 1989–2005Source: 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? (3)

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
*K934591Clave Vial Access Spike
Summary page 1
…One Time Vial Access Needle*Less Drug Vial Spike Spike Adapter 510(k)#: K934591 K934561 K894177 Device Description: The Drug Access Spike is a plastic conduit that is a…
Icu Medical, Inc.1994—
*K934561One Time Vial Access Spike
Summary page 1
…Needle*Less Drug Vial Spike Spike Adapter 510(k)#: K934591 K934561 K894177 Device Description: The Drug Access Spike is a plastic conduit that is a means to access drug contai…
Icu Medical, Inc.1994—
*K894177Needle*Less Drug Vial Adapter
Summary page 1
…Spike Spike Adapter 510(k)#: K934591 K934561 K894177 Device Description: The Drug Access Spike is a plastic conduit that is a means to access drug containers. The device is center o…
Baxter Healthcare Corp1989—
†K011193Nac Plus Needleless Access ConnectorPorex Medical Products2001—
†K992268Nac PRN Needleless Access ConnectorThe Kipp Group1999—

Also cleared against K934591: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 3 ancestors has a recall.
  • 2 other devices also cite its predicate K934591.

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)—

What is it indicated for?

The Drug Access Spike is a device used to aspirate solutions/medications from a drug container (drug vial/bag). The Drug Access Spike may incorporate componentry that aid in the prevention of accidental needle sticks.

Indications for use as stated in the FDA summary.

Also cleared against K934591

2 other devices cite the same predicate.

  • K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc. · 20082 Class I recalls
  • K080989Universal Vial Access SpikeIcu Medical, Inc. · 20081 recall

More from Medegen Medical Manufacturing Services

4 FDA decisions under this applicant name. See the company

  • K083765Maxguard Advanced Luer Activated Device with AntimicrobialMedegen Medical Manufacturing Services · 2008
  • K052330Tru-Swab StocockMedegen Medical Manufacturing Services · 2005
  • K051499Intravascular Administration Set and Extension SetMedegen Medical Manufacturing Services · 200524 recalls

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/K051930 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051930: Drug Access Spike.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051930

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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