510(k) Report

510(k) · Cleared

Cleared

IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter

K251669510(k) TraditionalCleared Sep 30, 2025123-day reviewClass II21 CFR 870.2900

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

Shanghai Draeger Medical Instrument Co., Ltd. · DSA Cable, Transducer And Electrode, Patient, (Including Connector)

Cleared on Sep 30, 2025 as substantially equivalent to K162768 (Integral Process Sas, 2017) after a 123-day review. Its family tree reaches back 4 generations to 2000.

Decided
Sep 30, 2025
Review
123 days
Class
Class II
Product code
DSA
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K992524 (2000). No later device cites it as a predicate yet.

K992524 · Patient Cables for Monitoring, I.E., Ecg, Ekg, SPO2, and BP Interface Cables and Leadwires · Advantage Medical Electronics, Inc. · 2000K082959 · Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure Monitors · Unimed Medical Supplies, Inc. · 2008K120010 · Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure) · Shenzhen Med-Link Electronics Tech Co., Ltd. · 2012K162768 · ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables · Integral Process Sas · 2017200020052010201520202025
K162768 · ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables · Integral Process Sas · 2017K120010 · Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure) · Shenzhen Med-Link Electronics Tech Co., Ltd. · 2012K082959 · Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure Monitors · Unimed Medical Supplies, Inc. · 2008K992524 · Patient Cables for Monitoring, I.E., Ecg, Ekg, SPO2, and BP Interface Cables and Leadwires · Advantage Medical Electronics, Inc. · 20000
  1. Root · 4 generations backK992524 Patient Cables for Monitoring, I.E., Ecg, Ekg, SPO2, and BP…Advantage Medical Electronics, Inc. · 2000
  2. 3 generations backK082959 Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure…Unimed Medical Supplies, Inc. · 2008
  3. 2 generations backK120010 Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure)Shenzhen Med-Link Electronics Tech Co., Ltd. · 2012
  4. 1 generation backK162768 ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2…Integral Process Sas · 2017
  5. This deviceK251669 IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer…Shanghai Draeger Medical Instrument Co., Ltd. · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K992524Patient Cables for Monitoring, I.E., Ecg, Ekg, SPO2, and BP Interface Cables…Advantage Medical Electronics, Inc.2000—
−3K082959Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure MonitorsUnimed Medical Supplies, Inc.2008—
−2K120010Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure)Shenzhen Med-Link Electronics Tech Co., Ltd.2012—
−1K162768ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and…Integral Process Sas2017—
0 (this device)K251669IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter…Shanghai Draeger Medical Instrument Co., Ltd.2025—
FIG. 1 — Lineage of K251669, 2000–2025Source: 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 DSA? 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 DSA device

  1. #1 K252827 IBP cable Becton Dickinson (2606488); IBP…score 11.3 · 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
*K162768ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP…
Summary page 7
…er cables are equivalent to the following previously cleared device(s): IBP transducers interface cables, K162768, INTEGRAL PROCESS SAS, Class II…
Integral Process Sas2017—

Also cleared against K162768: 1 other device →

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?

  • The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 8.1 years on median.
  • None of the 4 ancestors has a recall.
  • 1 other device also cites its predicate K162768.

How does its category compare?

All DSA devices

DSA Cable, Transducer And Electrode, Patient, (Including Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · DSA

4in 2025

2007: 22008: 62010: 42011: 12012: 12013: 12014: 12016: 22017: 52018: 32019: 42020: 62021: 42022: 22023: 32024: 32025: 42026 (partial year): 1
2007high 6 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSA

105in 2025

2008: 59 days median2010: 55 days median2017: 140 days median2018: 84 days median2019: 140 days median2020: 177 days median2021: 164 days median2023: 240 days median2024: 102 days median2025: 105 days median
2007high 240 (2023) · low 55 (2010)2026

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

Recalls per year · DSA

1in 2022

2010: 22022: 1
2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DSA

67in 2025

2007: 42008: 112009: 52010: 12011: 42012: 82013: 232014: 672015: 342016: 282017: 52018: 162019: 112020: 312021: 72022: 492023: 292024: 402025: 67
2007high 67 (2014) · low 1 (2010)2025

MAUDE reports naming product code DSA, 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
20072—04
2008659011
20090—05
201045521
20111—04
20121—08
20131—023
20141—067
20150—034
20162—028
2017514005
2018384016
20194140011
20206177031
2021416407
20222—149
20233240029
20243102040
20254105067
20261—0—

What is it indicated for?

The reusable Drager IBP adapter cables are intended to forward electrical signals from pressure transducers to Drager Hemo devices (Pods).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K162768

1 other device cites the same predicate.

  • K252827IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP…Drägerwerk AG & Co. KGaA · 2025

More from Shanghai Draeger Medical Instrument…

3 FDA decisions under this applicant name. See the company

  • K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd. · 2026
  • K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065)…Shanghai Draeger Medical Instrument Co., Ltd. · 2026

Recent decisions in DSA

The DSA category page

  • K254114Baylis Connector CableBaylis Medical Technologies, Inc. · 2026
  • K252827IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP…Drägerwerk AG & Co. KGaA · 2025
  • K242986SpO2 Extension CableBeijing Rongrui-Century Science & Technology Co., Ltd. · 2025
  • K243545Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk…Philips Medizin Systeme Böblingen GmbH · 2025
  • K240087RT Carbon ECG LeadsIvy Biomedical Systems, Inc. · 2024

https://510kreport.com/device/K251669 · printed Nov 4, 2026

Cite this page

510(k) Report. “K251669: IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251669

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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