510(k) Report

510(k) · Cleared

Cleared

Abcom 1 Cardiac Output Monitor

K870857510(k) TraditionalCleared Nov 16, 1987258-day reviewClass II21 CFR 870.2880

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

Applied Biometrics, Inc. · JOP Transducer, Ultrasonic

Cleared on Nov 16, 1987 after a 258-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 14 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it.

Decided
Nov 16, 1987
Review
258 days
Class
Class II
Product code
JOP
Recalls
None
Predicates
0

13 later devices descend from it, 1 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2003: 2 descendants cleared2010: 1 descendant cleared2013: 2 descendants cleared2011: 1 descendant cleared2012: 1 descendant cleared, 1 with a Class I recall12014: 1 descendant cleared2017: 1 descendant cleared2025: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant cleared1990200020102020
  1. This deviceK870857 Abcom 1 Cardiac Output MonitorApplied Biometrics, Inc. · 1987
  2. Descendant · cites it directly · 12 of its ownK021174 Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 2003
  3. Descendant · 2 generations on · 11 of its ownK032491 Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc. · 2003
  4. Descendant · 3 generations on · 8 of its ownK094054 Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010
  5. Descendant · 4 generations on · 4 of its ownK110989 Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2011 · Recalled
  6. Descendant · 5 generations on · 1 of its ownK221821 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2003: 22010: 12011: 12012: 12013: 22014: 12017: 12022: 12023: 12025: 12026: 1
2003high 2 (2003) · low 0 (2004)2026

Class I recalls in this family

  • K112686 Next Gen Emg Endotracheal Tube4 generations on · 2012

Most influential descendants

Showing 5 of 13 · See all
  • K021174Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 2003 · cites it directly12descendants
  • K032491Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc. · 2003 · 2 generations on11descendants
  • K094054Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010 · 3 generations on8descendants
  • K110989Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2011 · 4 generations on4descendants
  • K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K870857Abcom 1 Cardiac Output MonitorApplied Biometrics, Inc.1987—
+1K021174Ecom Endotrachial Cardiac Output MonitorImagyn Surgical2003—
+2K032491Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc.2003—
+3K094054Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc.2010—
+4K110989Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc.201110
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
201010
201110
201211
201320
201410
201710
202210
202310
202510
202610
FIG. 1 — Lineage of K870857, 1987–2026Source: 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 JOP device

  1. #1 K242662 Falcon/Xpress (Falcon/Xpress)score 8.8 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

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? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K021174Ecom Endotrachial Cardiac Output MonitorImagyn Surgical200312

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.

  • K112686Next Gen Emg Endotracheal TubeMedtronic Xomed, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K021174 (Imagyn Surgical, 2003) has gone furthest, with 12 descendants of its own.

How does its category compare?

All JOP devices

JOP Transducer, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOP

2in 2024

2007: 12011: 12013: 12014: 12016: 12024: 2
2007high 2 (2024) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOP

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

Recalls per year · JOP

No recall names JOP since 2007.

Adverse event reports per year · JOP

2in 2025

2014: 12017: 22020: 22021: 32022: 12024: 12025: 2
2007high 3 (2021) · low 0 (2007)2025

MAUDE reports naming product code JOP, 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—00
20080—00
20090—00
20100—00
20111—00
20120—00
20131—00
20141—01
20150—00
20161—00
20170—02
20180—00
20190—00
20200—02
20210—03
20220—01
20230—00
20242—01
20250—02
20260—0—

More from Applied Biometrics, Inc.

3 FDA decisions under this applicant name. See the company

  • K912562ABCOM 2000Applied Biometrics, Inc. · 1992
  • K911320Extravascular Doppler (Evd) Ultra Blood Flow ProbeApplied Biometrics, Inc. · 1991

Recent decisions in JOP

The JOP category page

  • K242662Falcon/Xpress (Falcon/Xpress)Viasonix, Ltd. · 2024
  • K233976VasoGuard (V10, V8, V6, V4, V2)Corvascular Diagnostics, LLC · 2024
  • K153762Smartdop XT6Koven Technology, Inc. · 2016
  • K131623Smartdop XTKoven Technology, Inc. · 2014
  • K131860Vasculab VL4000 Photoplethysmograph with Pulse Volume RecordingUs Vascular, LLC · 2013

https://510kreport.com/device/K870857 · printed Nov 6, 2026

Cite this page

510(k) Report. “K870857: Abcom 1 Cardiac Output Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K870857

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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