510(k) Report

510(k) · Cleared

Cleared

Qflow 500 Perfusion Monitoring System

K013376510(k) TraditionalCleared May 8, 2002209-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

Hemedex Incorporated · DPW Flowmeter, Blood, Cardiovascular

Cleared on May 8, 2002 as substantially equivalent to K903633 (Transonic Systems, Inc., 1990) and 4 other predicates after a 209-day review. Its family tree reaches back 3 generations to 1988.

Decided
May 8, 2002
Review
209 days
Class
Class II
Product code
DPW
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K875179 (1988). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1990: 2 other ancestors1991: 1 other ancestorK875179 · Modified Laserflo Blood Perfusion Monitor, BPM403A · Tsi, Inc. · 1988K951832 · Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433 · Vasamedics, LLC · 1996K961368 · Trimflo Parenchymal Blood Flow Monitoring Probe Kit · Vasamedics, LLC · 19961985199019952000
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor K961368 · Trimflo Parenchymal Blood Flow Monitoring Probe Kit · Vasamedics, LLC · 1996K951832 · Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433 · Vasamedics, LLC · 1996K875179 · Modified Laserflo Blood Perfusion Monitor, BPM403A · Tsi, Inc. · 19880
  1. Root · 3 generations backK875179 Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
  2. 2 generations backK951832 Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434…Vasamedics, LLC · 1996
  3. 1 generation backK961368 Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC · 1996
  4. This deviceK013376 Qflow 500 Perfusion Monitoring SystemHemedex Incorporated · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K875179Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc.1988—
−2K951832Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433Vasamedics, LLC1996—
−1K961368Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC1996—
0 (this device)K013376Qflow 500 Perfusion Monitoring SystemHemedex Incorporated2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199020
199110
199710
FIG. 1 — Lineage of K013376, 1988–2002Source: 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
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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
*K903633Advance Laser Flowmeter, Alf 21
Summary page 1
…te or Legally Marketed Device QFlow™ 500 is substantially equivalent to the following predicate devices: Transonic Systems ALF 21 Advanced Laser Flowmeter cleared under K903633. TS| LaserFlo™ Blood Perfusion Monitor cleared under K896515. (Vasamedics purchased TSI in 1990) Vasomedics Laserflo Blood Perf…
Transonic Systems, Inc.1990—
*K896515Laserflo Blood Perfusion Monitor, Model BPM2
Summary page 1
…valent to the following predicate devices: Transonic Systems ALF 21 Advanced Laser Flowmeter cleared under K903633. TS| LaserFlo™ Blood Perfusion Monitor cleared under K896515. (Vasamedics purchased TSI in 1990) Vasomedics Laserflo Blood Perfusion Probes (K951832, K962700, K961368 ) Device Description…
Tsi, Inc.1990—
*K951832Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433
Summary page 1
…eter cleared under K903633. TS| LaserFlo™ Blood Perfusion Monitor cleared under K896515. (Vasamedics purchased TSI in 1990) Vasomedics Laserflo Blood Perfusion Probes (K951832, K962700, K961368 ) Device Description The QFlow™ 500 has application where real-time determination of any tissue perfusion is…
Vasamedics, LLC1996—
*K962700Ventricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo Blood Flow Monitoring…
Summary page 1
…red under K903633. TS| LaserFlo™ Blood Perfusion Monitor cleared under K896515. (Vasamedics purchased TSI in 1990) Vasomedics Laserflo Blood Perfusion Probes (K951832, K962700, K961368 ) Device Description The QFlow™ 500 has application where real-time determination of any tissue perfusion is desired,…
Vasamedics, LLC1997—
*K961368Trimflo Parenchymal Blood Flow Monitoring Probe Kit
Summary page 1
…K903633. TS| LaserFlo™ Blood Perfusion Monitor cleared under K896515. (Vasamedics purchased TSI in 1990) Vasomedics Laserflo Blood Perfusion Probes (K951832, K962700, K961368 ) Device Description The QFlow™ 500 has application where real-time determination of any tissue perfusion is desired, whether i…
Vasamedics, LLC1996—

Also cleared against K903633: 1 other device →

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 14 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
  • None of the 7 ancestors has a recall.
  • 1 other device also cites its predicate K903633.

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 QFlow™ 500 is intended for extravascular monitoring of microcirculation blood flow in buried tissues. Example of this application included (but are not limited to) 1) the monitoring of buried muscle or esophagus following free muscle transfer or esophageal reconstruction, 2) monitoring soft tissue microcirculation following reconstructive surgery, such as oral and facial reconstruction, 3) monitoring cerebral blood flow during and following neurosurgery for head trauma.

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 K903633

1 other device cites the same predicate.

  • K140740Transonic Tissue Perfusion MonitorTransonic Systems, Inc. · 2015

More from Hemedex Incorporated

4 FDA decisions under this applicant name. See the company

  • K141869Qflow 500 Titanium Bolt, Quad Lumen Bolt KitHemedex Incorporated · 2014
  • K032127Hemedex Fixation DeviceHemedex Incorporated · 2003
  • K032337Hemedex Cranial Bolt Models, 3601, 3602Hemedex Incorporated · 2003

Recent decisions in DPW

The DPW category page

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https://510kreport.com/device/K013376 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013376: Qflow 500 Perfusion Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013376

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026