510(k) Report

510(k) · Cleared

Cleared

Cbis Catheter Pull-Back Device

K921879510(k) TraditionalCleared Jul 16, 199287-day reviewClass II21 CFR 870.1200

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

Cardiovascular Imaging Systems, Inc. · DQO Catheter, Intravascular, Diagnostic

Cleared on Jul 16, 1992 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 34 devices in its family, counting itself, has a Class I recall. 33 later devices descend from it.

Decided
Jul 16, 1992
Review
87 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
0

33 later devices descend from it, 1 citing it directly. 1 of the 34 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1998: 1 descendant cleared2005: 1 descendant cleared2018: 2 descendants cleared, 1 with a Class I recall12008: 3 descendants cleared2016: 1 descendant cleared2013: 4 descendants cleared2026: 2 descendants cleared2011: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2015: 3 descendants cleared2019: 4 descendants cleared2017: 3 descendants cleared2024: 1 descendant cleared2025: 1 descendant cleared2022: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant cleared2021: 1 descendant cleared1990200020102020
  1. This deviceK921879 Cbis Catheter Pull-Back DeviceCardiovascular Imaging Systems, Inc. · 1992
  2. Descendant · cites it directly · 32 of its ownK974457 Scout 3.2/45 MHZ Coronary Imaging Catheter, Scout 3.2/45 MHZ…Hewlett-Packard Co. · 1998
  3. Descendant · 2 generations on · 31 of its ownK050995 Revolution 45 MHZ Rotational Ivus Imaging CatheterVolcano Corporation · 2005
  4. Descendant · 3 generations on · 28 of its ownK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
  5. Descendant · 4 generations on · 25 of its ownK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
  6. Descendant · 5 generations on · 24 of its ownK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

1998: 12005: 12008: 32011: 12012: 12013: 42014: 12015: 32016: 12017: 32018: 22019: 42020: 12021: 12022: 12023: 12024: 12025: 12026: 2
1998high 4 (2013) · low 0 (1999)2026

Class I recalls in this family

  • K172258 Novasight Hybrid System3 generations on · 2018

Most influential descendants

Showing 5 of 33 · See all
  • K974457Scout 3.2/45 MHZ Coronary Imaging Catheter, Scout 3.2/45 MHZ Coronary Imaging Catheter…Hewlett-Packard Co. · 1998 · cites it directly32descendants
  • K050995Revolution 45 MHZ Rotational Ivus Imaging CatheterVolcano Corporation · 2005 · 2 generations on31descendants
  • K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · 3 generations on28descendants
  • K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemVolcano Corporation · 2008 · 4 generations on25descendants
  • K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · 5 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K921879Cbis Catheter Pull-Back DeviceCardiovascular Imaging Systems, Inc.1992—
+1K974457Scout 3.2/45 MHZ Coronary Imaging Catheter, Scout 3.2/45 MHZ Coronary Imaging…Hewlett-Packard Co.1998—
+2K050995Revolution 45 MHZ Rotational Ivus Imaging CatheterVolcano Corporation2005—
+3K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation20082
+4K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and…Volcano Corporation20083
+5K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation20111

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200510
200830
201110
201210
201340
201410
201530
201610
201730
201821
201940
202010
202110
202210
202310
202410
202510
202620
FIG. 1 — Lineage of K921879, 1992–2026Source: 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.

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.

Top candidate predicates for a new DQO device

  1. #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (33)

See all 33

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

NumberDeviceApplicantDecidedDescendants
K974457Scout 3.2/45 MHZ Coronary Imaging Catheter, Scout 3.2/45 MHZ Coronary Imaging Catheter…Hewlett-Packard Co.199832

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

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K172258Novasight Hybrid SystemConavi Medical, Inc. · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K974457 (Hewlett-Packard Co., 1998) has gone furthest, with 32 descendants of its own.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQO

2in 2025

2007: 82008: 32009: 82010: 72011: 62012: 152013: 22014: 32015: 102016: 42017: 102018: 102019: 62020: 32021: 12022: 42023: 42024: 42025: 22026 (partial year): 3
2007high 15 (2012) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQO

148in 2024

2007: 106 days median2008: 80 days median2009: 58 days median2010: 137 days median2011: 74 days median2012: 94 days median2014: 109 days median2015: 209 days median2016: 89 days median2017: 176 days median2018: 234 days median2019: 113 days median2020: 30 days median2022: 181 days median2023: 73 days median2024: 148 days median2026 (partial year): 85 days median
2007high 234 (2018) · low 30 (2020)2026

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

Recalls per year · DQO

1in 2023

2007: 142008: 42009: 72010: 112011: 72012: 22013: 12015: 1, 1 Class I2016: 2, 1 Class I2017: 12018: 22019: 712020: 4, 4 Class I2022: 12023: 1, 1 Class I2026 (partial year): 24, 4 Class I
2007high 71 (2019) · low 0 (2014)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · DQO

656in 2025

2007: 5642008: 7262009: 9332010: 5562011: 6252012: 5322013: 7532014: 6012015: 6282016: 6142017: 8732018: 7772019: 3862020: 3122021: 3382022: 3792023: 3912024: 5112025: 656
2007high 933 (2009) · low 312 (2020)2025

MAUDE reports naming product code DQO, 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
2007810614564
20083804726
20098587933
2010713711556
20116747625
201215942532
20132—1753
201431090601
2015102091 (1)628
20164892 (1)614
2017101761873
2018102342777
2019611371386
20203304 (4)312
20211—0338
202241811379
20234731 (1)391
202441480511
20252—0656
202638524 (4)—

More from Cardiovascular Imaging Systems, Inc.

19 FDA decisions under this applicant name. See the company

  • K970049BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath Ultra Imaging Catheter…Cardiovascular Imaging Systems, Inc. · 1997
  • K942231Microview II/Microrail II CathetersCardiovascular Imaging Systems, Inc. · 1994
  • K933517Automatic Pull Back DeviceCardiovascular Imaging Systems, Inc. · 1993
  • K930232Cvis Insight Imaging Guide CatheterCardiovascular Imaging Systems, Inc. · 1993
  • K924922Cvis Insight Imaging CatheterCardiovascular Imaging Systems, Inc. · 1993

Recent decisions in DQO

The DQO category page

  • K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF…Bioptimal International Pte., Ltd. · 2026
  • K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K250751DualView CatheterTerumo Corporation · 2025
  • K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC · 20251 recall

https://510kreport.com/device/K921879 · printed Nov 4, 2026

Cite this page

510(k) Report. “K921879: Cbis Catheter Pull-Back Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K921879

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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