510(k) Report

510(k) · Decided

Decided

Medical Procedure Kits/Arterial Blood Sampling

K905464510(k) TraditionalDecided May 31, 1991177-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

Angiosystems, Inc. · CBT Arterial Blood Sampling Kit

Cleared on May 31, 1991 after a 177-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
May 31, 1991
Review
177 days
Class
Class I
Product code
CBT
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1990200020102020
  1. This deviceK905464 Medical Procedure Kits/Arterial Blood SamplingAngiosystems, Inc. · 1991
  2. Descendant · cites it directly · 0 of its ownK962596 Customed Blood Extraction KitCustomed, Inc. · 1996

Most influential descendants

Showing 1 of 1 · See all
  • K962596Customed Blood Extraction KitCustomed, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K905464Medical Procedure Kits/Arterial Blood SamplingAngiosystems, Inc.1991—
+1K962596Customed Blood Extraction KitCustomed, Inc.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K905464, 1991–1996Source: 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), 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?

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

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K962596Customed Blood Extraction KitCustomed, Inc.19960

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?

  • Of its descendants, K962596 (Customed, Inc., 1996) has gone furthest, with 0 descendants of its own.

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—

More from Angiosystems, Inc.

14 FDA decisions under this applicant name. See the company

  • K905459Surgical Procedure Tray/Laparoscopy CholecystectomAngiosystems, Inc. · 1991
  • K905461Procedure Kit/Routine Dental ProceduresAngiosystems, Inc. · 1991
  • K905465Sterile Dispos Surgical Drape/C-Section DrapeAngiosystems, Inc. · 1991
  • K905466Sterile Disposable Surgical Drape/Abdominal DrapeAngiosystems, Inc. · 1991
  • K905460Sterile Disposable Drape/Ophthalmic SurgeryAngiosystems, Inc. · 1991

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
  • K955663Abc in-Line Blood Sampling KitUtah Medical Products, Inc. · 1997
  • K954015Abg Point Lok Needle Protection DeviceDevon Industries, Inc. · 19953 recalls
  • K954035Acti-Flex Arterial Extension SetR-Group Intl. · 1995

https://510kreport.com/device/K905464 · printed Nov 6, 2026

Cite this page

510(k) Report. “K905464: Medical Procedure Kits/Arterial Blood Sampling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905464

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