510(k) Report

510(k) · Cleared

Recalled · Class I · 2026

Stopcocks, Manifolds

K782095510(k) TraditionalCleared Jan 23, 197936-day reviewClass II21 CFR 870.4290Recalls 7 (3 Class I)

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

Namic · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Cleared on Jan 23, 1979 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has a Class I recall. It has been recalled 7 times, including 3 Class I recalls.

Decided
Jan 23, 1979
Review
36 days
Class
Class II
Product code
DTL
Recalls
7 (3 Class I)
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K782095Source: FDA 510(k) database · 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.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 24, 2026Class IZ-2139-2026Under Investigation by firmMedline has identified the presence of particulate within the fluid path of the Manifolds.
Mar 24, 2026Class IZ-2140-2026Under Investigation by firmMedline has identified the presence of particulate within the fluid path of the Manifolds.
Mar 24, 2026Class IZ-2138-2026Under Investigation by firmMedline has identified the presence of particulate within the fluid path of the Manifolds.
Aug 6, 2021Class IIZ-2574-2021Process designPotential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
Aug 6, 2021Class IIZ-2575-2021Process designPotential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
Aug 6, 2008Not classifiedZ-0287-2009Process designFirm became aware that a specific batch of the product may contain loose plastic particulates in the fluid pathway.
May 5, 2004Not classifiedZ-1393-05OtherMolded handles used in Angiographic Manifolds may be occluded.

The 5 latest of 7 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All DTL devices

DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTL

1in 2015

2007: 12008: 52009: 22010: 42012: 82013: 12014: 22015: 1
2007high 8 (2012) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTL

36in 2012

2008: 85 days median2010: 115 days median2012: 36 days median
2007high 115 (2010) · low 36 (2012)2026

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

Recalls per year · DTL

1in 2025

2008: 12010: 32011: 12012: 22013: 1, 1 Class I2014: 12017: 22022: 22025: 12026 (partial year): 3, 3 Class I
2007high 3 (2010) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · DTL

110in 2025

2007: 372008: 162009: 622010: 1482011: 1602012: 532013: 672014: 802015: 892016: 672017: 1062018: 842019: 762020: 532021: 552022: 482023: 462024: 4522025: 110
2007high 452 (2024) · low 16 (2008)2025

MAUDE reports naming product code DTL, 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
20071—037
2008585116
20092—062
201041153148
20110—1160
2012836253
20131—1 (1)67
20142—180
20151—089
20160—067
20170—2106
20180—084
20190—076
20200—053
20210—055
20220—248
20230—046
20240—0452
20250—1110
20260—3 (3)—

More from Namic

8 FDA decisions under this applicant name. See the company

  • K953676Breeze Digital Inflation DeviceNamic · 1996
  • K951722Perceptor Compensator Morse ManifoldNamic · 1996
  • K921322Morse Anesthesia ManifoldNamic · 1993
  • K822100High Pressure Contrast Injection LineNamic · 1982
  • K813549Continuous Flush DeviceNamic · 1982

Recent decisions in DTL

The DTL category page

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  • K143429Passage Hemostasis ValveMerit Medical Systems, Inc. · 2014
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  • K123448Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock Adapter with…Medtronic, Inc. · 2012

https://510kreport.com/device/K782095 · printed Nov 6, 2026

Cite this page

510(k) Report. “K782095: Stopcocks, Manifolds.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K782095

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026