510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Transonic Flow-QC Set Model ADT1010

K021571510(k) TraditionalCleared Aug 12, 200290-day reviewClass II21 CFR 876.5820Recalls 1

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

Transonic Systems, Inc. · MQS System, Hemodialysis, Access Recirculation Monitoring

Cleared on Aug 12, 2002 as substantially equivalent to K002816 (Transonic Systems, Inc., 2000) after a 90-day review. Its family tree reaches back 1 generation to 2000. It has been recalled once.

Decided
Aug 12, 2002
Review
90 days
Class
Class II
Product code
MQS
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K002816 (2000). No later device cites it as a predicate yet.

K002816 · Transonic Hemodialysis Flow Reverser, Model B Flowrev · Transonic Systems, Inc. · 2000200020022004
K002816 · Transonic Hemodialysis Flow Reverser, Model B Flowrev · Transonic Systems, Inc. · 20000
  1. Root · 1 generation backK002816 Transonic Hemodialysis Flow Reverser, Model B FlowrevTransonic Systems, Inc. · 2000
  2. This deviceK021571 Transonic Flow-QC Set Model ADT1010Transonic Systems, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002816Transonic Hemodialysis Flow Reverser, Model B FlowrevTransonic Systems, Inc.2000—
0 (this device)K021571Transonic Flow-QC Set Model ADT1010Transonic Systems, Inc.2002—
FIG. 1 — Lineage of K021571, 2000–2002Source: 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 MQS? 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 MQS device

  1. #1 K232283 PhySoftAMS®score 8.0 · 6 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (1)

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
*K002816Transonic Hemodialysis Flow Reverser, Model B FlowrevTransonic Systems, Inc.2000—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 15, 2018Class IIZ-1776-2018Process controlThe sterility of the device cannot be assured. There is a potential for an increased risk of infection.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All MQS devices

MQS System, Hemodialysis, Access Recirculation Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQS

1in 2023

2013: 12019: 12023: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQS

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

Recalls per year · MQS

No recall names MQS since 2007.

Adverse event reports per year · MQS

5in 2013

2007: 682008: 62009: 212010: 102011: 12012: 52013: 5
2007high 68 (2007) · low 0 (2014)2025

MAUDE reports naming product code MQS, 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
20070—068
20080—06
20090—021
20100—010
20110—01
20120—05
20131—05
20140—00
20150—00
20160—00
20170—00
20180—00
20191—00
20200—00
20210—00
20220—00
20231—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Transonic Flow-QC Set is indicated for use as part of an extracorporeal blood circuit for hemodialysis when the Transonic HDOl System will be use to make access flow, recirculation, and/or cardiac output measurements during the patient’s hemodialysis treatment.

Indications for use as stated in the FDA summary.

More from Transonic Systems, Inc.

16 FDA decisions under this applicant name. See the company

  • K140740Transonic Tissue Perfusion MonitorTransonic Systems, Inc. · 2015
  • K134051Transonic Elsa SystemTransonic Systems, Inc. · 2015
  • K134035Transonic HCM 103 SystemTransonic Systems, Inc. · 2014
  • K140017Transonic HCM 102 SystemTransonic Systems, Inc. · 2014
  • K113821Transonic Costatus Cardiac Output SystemTransonic Systems, Inc. · 2012

Recent decisions in MQS

The MQS category page

  • K232283PhySoftAMS®Physician Software Systems, LLC · 2023
  • K180410Dosis SAMDosis, Inc. · 2019
  • K130579Physoft AmsPhysicians Software Systems, LLC · 2013
  • K042566Vasc-AlertVasc-Alert, Inc. · 2004
  • K022963Transonic Syringe Warmer, Model Syr-1000Transonic Systems, Inc. · 2002

https://510kreport.com/device/K021571 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021571: Transonic Flow-QC Set Model ADT1010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021571

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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