510(k) Report

510(k) · Cleared

Cleared

Talley TM300 Sequential Multicom Compression Syst

K915092510(k) TraditionalCleared Feb 11, 199282-day reviewClass II21 CFR 890.5650

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

Progressive Medical Technology, Inc. · IRP Massager, Powered Inflatable Tube

Cleared on Feb 11, 1992 after an 82-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 35 later devices descend from it.

Decided
Feb 11, 1992
Review
82 days
Class
Class II
Product code
IRP
Recalls
None
Predicates
0

35 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2006: 3 descendants cleared2000: 2 descendants cleared2010: 1 descendant cleared2011: 2 descendants cleared2012: 3 descendants cleared2008: 1 descendant cleared2016: 2 descendants cleared2024: 3 descendants cleared2020: 3 descendants cleared2021: 4 descendants cleared2014: 2 descendants cleared2018: 1 descendant cleared2013: 1 descendant cleared2017: 2 descendants cleared2019: 1 descendant cleared2015: 1 descendant cleared2023: 2 descendants cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK915092 Talley TM300 Sequential Multicom Compression SystProgressive Medical Technology, Inc. · 1992
  2. Descendant · cites it directly · 31 of its ownK993758 Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
  3. Descendant · 2 generations on · 30 of its ownK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
  4. Descendant · 3 generations on · 10 of its ownK062818 Flexitouch SystemTactile Systems Technology, Inc. · 2006
  5. Descendant · 4 generations on · 9 of its ownK120972 Flexitouch SystemTactile Systems Technology, Inc. · 2012
  6. Descendant · 3 generations on · 9 of its ownK110159 Activecare SFTMedical Compression Systems (Dbn), Ltd. · 2011

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2000: 22006: 32008: 12010: 12011: 22012: 32013: 12014: 22015: 12016: 22017: 22018: 12019: 12020: 32021: 42023: 22024: 32026: 1
2000high 4 (2021) · low 0 (2001)2026

Most influential descendants

Showing 5 of 35 · See all
  • K993758Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000 · cites it directly31descendants
  • K060146Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · 2 generations on30descendants
  • K062818Flexitouch SystemTactile Systems Technology, Inc. · 2006 · 3 generations on10descendants
  • K120972Flexitouch SystemTactile Systems Technology, Inc. · 2012 · 4 generations on9descendants
  • K110159Activecare SFTMedical Compression Systems (Dbn), Ltd. · 2011 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K915092Talley TM300 Sequential Multicom Compression SystProgressive Medical Technology, Inc.1992—
+1K993758Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd.2000—
+2K060146Activecare ++ SystemMedical Compression Systems (Dbn), Ltd.20061
+3K062818Flexitouch SystemTactile Systems Technology, Inc.2006—
+4K120972Flexitouch SystemTactile Systems Technology, Inc.2012—
+3K110159Activecare SFTMedical Compression Systems (Dbn), Ltd.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200020
200630
200810
201010
201120
201230
201310
201420
201510
201620
201720
201810
201910
202030
202140
202320
202430
202610
FIG. 1 — Lineage of K915092, 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.

Planning a device in IRP? 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 IRP device

  1. #1 K193354 Air Compression Therapy Devicescore 28.6 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (35)

See all 35

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K993758Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd.200031
K060091Alliance Medical Corporation Reprocessed Compression SleevesAlliance Medical Corp.20061
K994057Slendair 4000 Compression SystemMedical Compression Systems (Dbn), Ltd.20000

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?

  • Of its descendants, K993758 (Medical Compression Systems (Dbn), Ltd., 2000) has gone furthest, with 31 descendants of its own.

How does its category compare?

All IRP devices

IRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IRP

13in 2025

2007: 22008: 12009: 12010: 22011: 32012: 52013: 22014: 42015: 22016: 12017: 42018: 32019: 102020: 92021: 192022: 142023: 102024: 122025: 132026 (partial year): 12
2007high 19 (2021) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IRP

141in 2025

2011: 164 days median2012: 116 days median2014: 113 days median2017: 170 days median2018: 80 days median2019: 83 days median2020: 150 days median2021: 140 days median2022: 97 days median2023: 143 days median2024: 115 days median2025: 141 days median2026 (partial year): 172 days median
2007high 172 (2026) · low 80 (2018)2026

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

Recalls per year · IRP

2in 2017

2011: 12017: 2
2007high 2 (2017) · low 0 (2007)2026

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

Adverse event reports per year · IRP

10in 2025

2008: 22009: 12010: 52011: 32012: 32015: 32016: 22020: 12022: 12024: 42025: 10
2007high 10 (2025) · low 0 (2007)2025

MAUDE reports naming product code IRP, 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
20072—00
20081—02
20091—01
20102—05
2011316413
2012511603
20132—00
2014411300
20152—03
20161—02
2017417020
201838000
2019108300
2020915001
20211914000
2022149701
20231014300
20241211504
202513141010
2026121720—
Cite this page

510(k) Report. “K915092: Talley TM300 Sequential Multicom Compression Syst.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K915092

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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