510(k) Report

510(k) · Cleared

Cleared

Vial Adapter 15mm

K171796510(k) SpecialCleared Oct 12, 2017118-day reviewClass II21 CFR 880.5440

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medimop Medical Project, Ltd. · LHI Set, I.V. Fluid Transfer

Cleared on Oct 12, 2017 as substantially equivalent to K963583 (Medimop Medical Projects, Ltd., 1996) after a 118-day review. Its family tree reaches back 1 generation to 1996. 6 later devices descend from it.

Decided
Oct 12, 2017
Review
118 days
Class
Class II
Product code
LHI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K963583 (1996). 6 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2019: 2 descendants cleared2023: 2 descendants cleared2024: 2 descendants clearedK963583 · Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Preattached Needle · Medimop Medical Projects, Ltd. · 19961995200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 2 descendants K963583 · Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Preattached Needle · Medimop Medical Projects, Ltd. · 19960
  1. Root · 1 generation backK963583 Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable…Medimop Medical Projects, Ltd. · 1996
  2. This deviceK171796 Vial Adapter 15mmMedimop Medical Project, Ltd. · 2017
  3. Descendant · cites it directly · 2 of its ownK222718 Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2023
  4. Descendant · 2 generations on · 0 of its ownK233287 Vent Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2024
  5. Descendant · 2 generations on · 0 of its ownK233284 Vial Adapter with FilterHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2024
  6. Descendant · cites it directly · 0 of its ownK232055 Vial AdapterShanghai Lingfu Technology Co., Ltd. · 2023
  7. Descendant · cites it directly · 0 of its ownK190816 Vial Adapter Ø20 mm , Vial Adapter Ø13 mmAvenir Performance Europeenne Medical (Apem) · 2019

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2019: 22023: 22024: 2
2019high 2 (2019) · low 0 (2020)2026

Most influential descendants

Showing 5 of 6 · See all
  • K222718Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2023 · cites it directly2descendants
  • K233287Vent Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2024 · 2 generations on0descendants
  • K233284Vial Adapter with FilterHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2024 · 2 generations on0descendants
  • K232055Vial AdapterShanghai Lingfu Technology Co., Ltd. · 2023 · cites it directly0descendants
  • K190816Vial Adapter Ø20 mm , Vial Adapter Ø13 mmAvenir Performance Europeenne Medical (Apem) · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K963583Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder…Medimop Medical Projects, Ltd.1996—
0 (this device)K171796Vial Adapter 15mmMedimop Medical Project, Ltd.2017—
+1K222718Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.2023—
+2K233287Vent Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.2024—
+2K233284Vial Adapter with FilterHangzhou Qiantang Longyue Biotechnology Co., Ltd.2024—
+1K232055Vial AdapterShanghai Lingfu Technology Co., Ltd.2023—
+1K190816Vial Adapter Ø20 mm , Vial Adapter Ø13 mmAvenir Performance Europeenne Medical (Apem)2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201920
202320
202420
FIG. 1 — Lineage of K171796, 1996–2024Source: 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 LHI? 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 LHI device

  1. #1 K252987 ADRx™ Admixture Devicescore 12.4 · 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? (1)

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
*K963583Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and…
Summary page 5
…ion No.: 880.5440 Class: II Panel Identification: General Hospital Panel Predicate Devices: Mixject Dispensing Pin – K963583 Vial Adapter 15mm Special 510(k)…
Medimop Medical Projects, Ltd.1996—

Also cleared against K963583: 5 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K222718Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.20232
K232055Vial AdapterShanghai Lingfu Technology Co., Ltd.20230
K190816Vial Adapter Ø20 mm , Vial Adapter Ø13 mmAvenir Performance Europeenne Medical (Apem)20190
K190149Vial Adapter Ø20 mmAvenir Performance Europeenne Medical (Apem)20190

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?

  • Its one ancestor has no recall.
  • Of its descendants, K222718 (Hangzhou Qiantang Longyue Biotechnology Co., Ltd., 2023) has gone furthest, with 2 descendants of its own.
  • 5 other devices also cite its predicate K963583.

How does its category compare?

All LHI devices

LHI Set, I.V. Fluid Transfer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · LHI

6in 2025

2007: 32008: 42009: 82010: 52011: 32012: 52013: 42014: 62015: 32016: 32017: 52018: 12019: 42020: 32021: 32022: 62023: 52024: 92025: 62026 (partial year): 2
2007high 9 (2024) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LHI

196in 2025

2007: 89 days median2008: 154 days median2009: 95 days median2010: 139 days median2011: 99 days median2012: 127 days median2013: 102 days median2014: 63 days median2015: 99 days median2016: 159 days median2017: 56 days median2019: 247 days median2020: 189 days median2021: 396 days median2022: 278 days median2023: 90 days median2024: 166 days median2025: 196 days median
2007high 396 (2021) · low 56 (2017)2026

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

Recalls per year · LHI

1in 2024

2007: 12008: 32009: 12010: 32011: 122013: 32016: 1, 1 Class I2017: 12018: 3, 3 Class I2019: 12022: 22023: 2, 2 Class I2024: 12026 (partial year): 1
2007high 12 (2011) · low 0 (2012)2026

Class I (6 since 2007) Class II/III not classified

Adverse event reports per year · LHI

1,334in 2025

2007: 182008: 272009: 372010: 492011: 1552012: 5292013: 1542014: 1552015: 1282016: 2192017: 5362018: 1,4992019: 1,6342020: 1,1712021: 9332022: 1,8342023: 1,0472024: 1,2702025: 1,334
2007high 1,834 (2022) · low 18 (2007)2025

MAUDE reports naming product code LHI, 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
2007389118
20084154327
2009895137
20105139349
201139912155
201251270529
201341023154
20146630155
20153990128
201631591 (1)219
20175561536
20181—3 (3)1,499
2019424711,634
2020318901,171
202133960933
2022627821,834
20235902 (2)1,047
2024916611,270
2025619601,334
20262—1—

What is it indicated for?

The Vial Adapter 15mm is indicated for the transfer and mixing of drugs contained in vials

Indications for use as stated in the FDA summary.

Also cleared against K963583

5 other devices cite the same predicate.

  • K130179MP Vial Adapter 13MMMedimop Medical Projects, Ltd. · 2013
  • K132040Vial Connector 13MM Closed CollarMedimop Medical Projects, Ltd. · 2013
  • K122023Mixject with Spray HeadMedimop Medical Projects, Ltd. · 2012
  • K062482Vented Vial Adapter Transfer DeviceMedimop Medical Projects, Ltd. · 2006
  • K041691Clip 'N'ject Reconstitution System (Clip 'N'jectWest Pharmaceutical Services, Inc. · 2004

More from Medimop Medical Project, Ltd.

2 FDA decisions under this applicant name. See the company

  • K170095Vial2Bag Direct ConnectMedimop Medical Project, Ltd. · 20172 Class I recalls

Recent decisions in LHI

The LHI category page

  • K252987ADRx™ Admixture DeviceEpic Medical Pte., Ltd. · 2026
  • K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2026
  • K250345Medline Bag DecanterMedline Industries, LP · 2025
  • K251715FlowArt® Vial Access Device VentedAsset Medikal · 2025
  • K251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S)…Microtek Medical, LLC · 2025

https://510kreport.com/device/K171796 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171796: Vial Adapter 15mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171796

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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