510(k) Report

510(k) · Cleared

Cleared

Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel Stabilizer

K050088510(k) SpecialCleared Feb 8, 200526-day reviewClass II21 CFR 870.2100

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

Neoprobe Corp. · DPW Flowmeter, Blood, Cardiovascular

Cleared on Feb 8, 2005 as substantially equivalent to K013803 (Biosonix, Ltd., 2002) and 4 other predicates after a 26-day review. Its family tree reaches back 5 generations to 1985.

Decided
Feb 8, 2005
Review
26 days
Class
Class II
Product code
DPW
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K851426 (1985). 13 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 2 other ancestors1988: 1 other ancestor1989: 2 other ancestors1995: 1 other ancestor1993: 1 other ancestor1986: 1 other ancestorK851426 · Accucom Cardiac Output Monitor · Lawrence Medical Systems, Inc. · 1985K972798 · Dynemo 3000 · Sometec, Inc. · 1998K013803 · Flowguard Device · Biosonix, Ltd. · 2002K030357 · Quantix/or Device · Cardiosonix, Ltd. · 2003 · recalledK041180 · Quantix or Vessel Stabilizer Device · Cardiosonix, Ltd. · 200419851990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 4 other ancestors K041180 · Quantix or Vessel Stabilizer Device · Cardiosonix, Ltd. · 2004K030357 · Quantix/or Device · Cardiosonix, Ltd. · 2003 · recalledK013803 · Flowguard Device · Biosonix, Ltd. · 2002K972798 · Dynemo 3000 · Sometec, Inc. · 1998K851426 · Accucom Cardiac Output Monitor · Lawrence Medical Systems, Inc. · 1985−50
  1. Root · 5 generations backK851426 Accucom Cardiac Output MonitorLawrence Medical Systems, Inc. · 1985
  2. 4 generations backK972798 Dynemo 3000Sometec, Inc. · 1998
  3. 3 generations backK013803 Flowguard DeviceBiosonix, Ltd. · 2002
  4. 2 generations backK030357 Quantix/or DeviceCardiosonix, Ltd. · 2003 · Recalled
  5. 1 generation backK041180 Quantix or Vessel Stabilizer DeviceCardiosonix, Ltd. · 2004
  6. This deviceK050088 Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel…Neoprobe Corp. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K851426Accucom Cardiac Output MonitorLawrence Medical Systems, Inc.1985—
−4K972798Dynemo 3000Sometec, Inc.1998—
−3K013803Flowguard DeviceBiosonix, Ltd.2002—
−2K030357Quantix/or DeviceCardiosonix, Ltd.20032
−1K041180Quantix or Vessel Stabilizer DeviceCardiosonix, Ltd.2004—
0 (this device)K050088Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel StabilizerNeoprobe Corp.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198810
198920
199310
199510
199920
FIG. 1 — Lineage of K050088, 1985–2005Source: 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 DPW? 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 DPW device

  1. #1 K251114 FloPatch FP120score 13.7 · 5 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? (5)

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
*K013803Flowguard Device
Our reading of the summary gave K018303, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “FlowGuard probe”.
Biosonix, Ltd.2002—
*K030357Quantix/or Device
Summary page 1
…) No. FlowGuard probe Biosonix, Ltd. K018303 Quantix/ORTM Blood Flow Monitor (Rigid probe) Cardiosonix, Ltd. K030357 Quantix/OR TM Vessel Stabilizer (Flexible probe) Cardiosonix, Ltd. K041180 Butterfly Flowmeter BF1000 - BF2004…
Cardiosonix, Ltd.20032
*K041180Quantix or Vessel Stabilizer Device
Summary page 1
…18303 Quantix/ORTM Blood Flow Monitor (Rigid probe) Cardiosonix, Ltd. K030357 Quantix/OR TM Vessel Stabilizer (Flexible probe) Cardiosonix, Ltd. K041180 Butterfly Flowmeter BF1000 - BF2004 Medi-Stim K992305 Flowmeter…
Cardiosonix, Ltd.2004—
*K992305Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004
Summary page 1
…30357 Quantix/OR TM Vessel Stabilizer (Flexible probe) Cardiosonix, Ltd. K041180 Butterfly Flowmeter BF1000 - BF2004 Medi-Stim K992305 Flowmeter Transonic K872048 1.8.4 Intended Use The Quantix/ORTM Flex…
Medi-Stim A/S1999—
*K872048Transonic Flowmeter
Summary page 1
…41180 Butterfly Flowmeter BF1000 - BF2004 Medi-Stim K992305 Flowmeter Transonic K872048 1.8.4 Intended Use The Quantix/ORTM Flexible Probe and optional Vessel Stabilizers are intended for invasive and noninvasiv…
Transonic Systems, Inc.198810

Also cleared against K013803: 2 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?

  • The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
  • 2 of the 13 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K013803.

How does its category compare?

All DPW devices

DPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPW

3in 2025

2007: 12008: 12010: 22011: 42012: 12013: 22015: 32016: 12018: 22019: 32020: 22021: 22022: 32023: 12024: 12025: 32026 (partial year): 2
2007high 4 (2011) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPW

119in 2025

2011: 89 days median2015: 275 days median2019: 169 days median2022: 136 days median2025: 119 days median
2007high 275 (2015) · low 89 (2011)2026

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

Recalls per year · DPW

1in 2025

2007: 42010: 12012: 12017: 12025: 1
2007high 4 (2007) · low 0 (2008)2026

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

Adverse event reports per year · DPW

6in 2025

2009: 12011: 12013: 32014: 82015: 122016: 12017: 22019: 32020: 42021: 62022: 12023: 22024: 42025: 6
2007high 12 (2015) · low 0 (2007)2025

MAUDE reports naming product code DPW, 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—40
20081—00
20090—01
20102—10
201148901
20121—10
20132—03
20140—08
20153275012
20161—01
20170—12
20182—00
2019316903
20202—04
20212—06
2022313601
20231—02
20241—04
2025311916
20262—0—

What is it indicated for?

The Quantix/OR Blood Flow Monitor is intended for invasive and noninvasive diagnostic blood flow measurements.

Indications for use as stated in the FDA summary.

Also cleared against K013803

2 other devices cite the same predicate.

  • K030357Quantix/or DeviceCardiosonix, Ltd. · 20032 recalls
  • K023431Quantix/ND DeviceCardiosonix, Ltd. · 2002

More from Neoprobe Corp.

6 FDA decisions under this applicant name. See the company

  • K971167Neoprobe Model 1500 Portable Radioisotope Detector and AccessoriesNeoprobe Corp. · 1997
  • K962319Neoprobe 1000 Gen 1C Portable Radioisotope Detector & AccessoriesNeoprobe Corp. · 1996
  • K942580Neoprobe 1000 Portable Radioisotope Detector and AccessoriesNeoprobe Corp. · 1995
  • K915279Neoprobe Portable Radioscope DetectorNeoprobe Corp. · 1992
  • K864263Neoprobe Portable Radioisotope DetectorNeoprobe Corp. · 1986

Recent decisions in DPW

The DPW category page

  • K260700BlueDop Vascular ExpertBlueDop Medical, Ltd. · 2026
  • K252810FloPatch FP120Flosonics Medical · 2026
  • K251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02…Remington Medical, Inc. · 2025
  • K251114FloPatch FP120Flosonics Medical · 2025
  • K243852Elfor-LElfi-Tech, Ltd. · 2025

https://510kreport.com/device/K050088 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050088: Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel Stabilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050088

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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