510(k) Report

510(k) · Cleared

Cleared

Merit Manifold with Integrated Transducer, Model 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L

K100319510(k) TraditionalCleared Apr 28, 201083-day reviewClass II21 CFR 870.4290

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

Merit Medical Systems, Inc. · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Cleared on Apr 28, 2010 as substantially equivalent to K913161 (Merit Medical Systems, Inc., 1991) and 2 other predicates after an 83-day review. Its family tree reaches back 1 generation to 1991.

Decided
Apr 28, 2010
Review
83 days
Class
Class II
Product code
DTL
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K913161 (1991). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestor1992: 1 other ancestorK913161 · Merit Manifold · Merit Medical Systems, Inc. · 199119901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors K913161 · Merit Manifold · Merit Medical Systems, Inc. · 19910
  1. Root · 1 generation backK913161 Merit ManifoldMerit Medical Systems, Inc. · 1991
  2. This deviceK100319 Merit Manifold with Integrated Transducer, Model 203LTCHN-R…Merit Medical Systems, Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K913161Merit ManifoldMerit Medical Systems, Inc.1991—
0 (this device)K100319Merit Manifold with Integrated Transducer, Model 203LTCHN-R; 503LTCHN-R…Merit Medical Systems, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199610
FIG. 1 — Lineage of K100319, 1991–2010Source: 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 DTL? 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? (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
*K913161Merit Manifold
Summary page 1
…(21 CFR 870.2850) Classification Panel: Cardiovascular PREDICATE DEVICE(S) * Merit Manifold (K913161) * Merit Meritrans Disposable Transducer (K920977) * Navilyst Perceptor Compensator Morse Manifold (1(951722) [combined…
Merit Medical Systems, Inc.1991—
*K920977Meritrans (TM) Disposable Transducer
Summary page 1
…70.2850) Classification Panel: Cardiovascular PREDICATE DEVICE(S) * Merit Manifold (K913161) * Merit Meritrans Disposable Transducer (K920977) * Navilyst Perceptor Compensator Morse Manifold (1(951722) [combined intended use] DEVICE DESCRIPTION The Merit Mani…
Merit Medical Systems, Inc.1992—
*K951722Perceptor Compensator Morse Manifold
Summary page 1
…cular PREDICATE DEVICE(S) * Merit Manifold (K913161) * Merit Meritrans Disposable Transducer (K920977) * Navilyst Perceptor Compensator Morse Manifold (1(951722) [combined intended use] DEVICE DESCRIPTION The Merit Manifold with Integrated Transducer (referred to as M-T in this subm…
Namic1996—

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.

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. 2010, this device’s year, is highlighted.

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)—

What is it indicated for?

The Merit Manifold with Integrated Transducer is used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices. The device is also used for measurement of blood pressure.

Indications for use as stated in the FDA summary.

More from Merit Medical Systems, Inc.

185 FDA decisions under this applicant name. See the company

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Recent decisions in DTL

The DTL category page

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https://510kreport.com/device/K100319 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100319: Merit Manifold with Integrated Transducer, Model 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100319

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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