510(k) Report

510(k) · Cleared

Cleared

Abc in-Line Blood Sampling Kit

K955663510(k) TraditionalCleared Mar 17, 1997460-day reviewClass I21 CFR 868.1100

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

Utah Medical Products, Inc. · CBT Arterial Blood Sampling Kit

Cleared on Mar 17, 1997 as substantially equivalent to K885281 (Baxter Healthcare Corp, 1989) after a 460-day review. Its family tree reaches back 1 generation to 1989.

Decided
Mar 17, 1997
Review
460 days
Class
Class I
Product code
CBT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K885281 (1989). No later device cites it as a predicate yet.

K885281 · Vamp Venous/Arterial Blood Management Protection · Baxter Healthcare Corp · 1989 · recalled1986198819901992199419961998
K885281 · Vamp Venous/Arterial Blood Management Protection · Baxter Healthcare Corp · 1989 · recalled0
  1. Root · 1 generation backK885281 Vamp Venous/Arterial Blood Management ProtectionBaxter Healthcare Corp · 1989 · Recalled
  2. This deviceK955663 Abc in-Line Blood Sampling KitUtah Medical Products, Inc. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K885281Vamp Venous/Arterial Blood Management ProtectionBaxter Healthcare Corp19891
0 (this device)K955663Abc in-Line Blood Sampling KitUtah Medical Products, Inc.1997—
FIG. 1 — Lineage of K955663, 1989–1997Source: 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 CBT? 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? (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
*K885281Vamp Venous/Arterial Blood Management Protection
Summary page 1
…into the patient to reduce fluid loss. Ao =7 e The device is substantially equivalent to the Baxter—V/AthTM blood sampling system cleared for marketing under 510(k) K/885281. “Although the ABC blood collection reservoir is of a different shape and larger capacity compared to the VAMP reservoir, the fre…
Baxter Healthcare Corp19891

Also cleared against K885281: 3 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?

  • Its one ancestor has a recall.
  • 3 other devices also cite its predicate K885281.

How does its category compare?

All CBT devices

CBT Arterial Blood Sampling Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CBT

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CBT

Too few CBT 510(k)s in any year since 2007 to give a median.

Recalls per year · CBT

14in 2011

2007: 22011: 142026 (partial year): 2
2007high 14 (2011) · low 0 (2008)2026

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

Adverse event reports per year · CBT

20in 2025

2007: 52008: 102009: 72010: 202011: 62012: 142013: 132014: 62015: 102016: 302017: 222018: 152019: 192020: 102021: 242022: 132023: 132024: 252025: 20
2007high 30 (2016) · low 5 (2007)2025

MAUDE reports naming product code CBT, 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—25
20080—010
20090—07
20100—020
20110—146
20120—014
20130—013
20140—06
20150—010
20160—030
20170—022
20180—015
20190—019
20200—010
20210—024
20220—013
20230—013
20240—025
20250—020
20260—2—

What is it indicated for?

The ABC (“Arterial Blood Collection) In-Line Blood Sampling Kit is a closed blood sampling system used in conjunction with continuous blood pressure monitoring in a critical care setting. The ABC Kit is designed for use with all disposable and reusable pressure transducers and for connection to central line catheters and arterial catheters. The ABC Kit is used for the drawing and retention within the line of heparinized blood from the catheter/cannula, allowing undiluted blood samples to be drawn from an in-line sampling site. At the completion of sample drawing, the mixed heparin/blood solution is reinfused into the patient to reduce fluid loss.

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 K885281

3 other devices cite the same predicate.

  • K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling…Smiths Medical Asd, Inc. · 2017
  • K161962VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC · 20168 recalls
  • K983372Bioport Closed Blood Sampling System, Model BT Xxxxxx- BPSunscope Intl., Inc. · 1999

More from Utah Medical Products, Inc.

38 FDA decisions under this applicant name. See the company

  • K143424Utah CVX-RipeUtah Medical Products, Inc. · 2015
  • K123310Finesse 3RD Generation (Models Finesse+ and Finesseii+)Utah Medical Products, Inc. · 2013
  • K101535BT-CathUtah Medical Products, Inc. · 2011
  • K063611Saline/ Contrast Media Infusion CatheterUtah Medical Products, Inc. · 2007
  • K001874Peripherally Inserted Central CatheterUtah Medical Products, Inc. · 2000

Recent decisions in CBT

The CBT category page

  • K071269Hemodraw Arterial Blood Sampling SystemSmiths Medical Asd, Inc. · 2007
  • K070340Secure Arterial Blood Sampling SystemSmiths Medical Asd, Inc. · 2007
  • K954015Abg Point Lok Needle Protection DeviceDevon Industries, Inc. · 19953 recalls
  • K954035Acti-Flex Arterial Extension SetR-Group Intl. · 1995
  • K950098Needle Safety CoverHammer-Plane, Inc. · 1995

https://510kreport.com/device/K955663 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955663: Abc in-Line Blood Sampling Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955663

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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