510(k) Report

510(k) · Cleared

Recalled · Class I · 2015

MOVES

K093261510(k) TraditionalCleared Mar 26, 2010158-day reviewClass II21 CFR 868.5925Recalls 2 (2 Class I)

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

Thornhill Research, Inc. · BTL Ventilator, Emergency, Powered (Resuscitator)

Cleared on Mar 26, 2010 as substantially equivalent to K013931 (Sequal Technologies, Inc., 2002) and 7 other predicates after a 158-day review. Its family tree reaches back 7 generations to 1991. 4 of the 71 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.

Decided
Mar 26, 2010
Review
158 days
Class
Class II
Product code
BTL
Recalls
2 (2 Class I)
Predicates
8

Its longest line of descent runs back 7 generations to K902859 (1991). 63 ancestors in all, the oldest K852650 (1985). 7 later devices descend from it, 2 citing it directly. 4 of the 71 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2005: 1 other ancestor2003: 2 other ancestors2002: 2 other ancestors2001: 4 other ancestors1994: 4 other ancestors2004: 2 other ancestors1999: 6 other ancestors1996: 6 other ancestors1995: 7 other ancestors1998: 7 other ancestors, 2 with a Class I recall21985: 1 other ancestor2000: 1 other ancestor1993: 1 other ancestor1991: 4 other ancestors1997: 1 other ancestor1992: 2 other ancestors1990: 3 other ancestors1988: 1 other ancestor2014: 1 descendant cleared2015: 1 descendant cleared2017: 2 descendants cleared2018: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant clearedReference device: K081844 · GE Datex-Ohmeda Avance · Datex-Ohmeda, Inc. · 2008 · recalledK902859 · Servo Ventilator 300 · Siemens Life Support Systems · 1991 · recalledK960010 · Servo Ventilator 300 Computer Interface · Siemens Elema AB · 1996K970839 · Servo Ventilator 300A · Siemens Elema AB · 1997 · recalledK992788 · Bear Cub 750 PSV · Bear Medical Systems, Inc. · 1999K013642 · AVEA · Bird Products Corp. · 2002 · Class I recallK032451 · Bird Tbird Vela Ventilator · Bird Products Corp. · 2004 · recalledK052554 · Modification to: Ivent 201 Portable Ventilator · Versamed Medical Systems, Inc. · 20051990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 11 other ancestors3 generations back: 10 other ancestors, 1 with a Class I recall14 generations back: 12 other ancestors, 1 with a Class I recall15 generations back: 15 other ancestors6 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants K052554 · Modification to: Ivent 201 Portable Ventilator · Versamed Medical Systems, Inc. · 2005K032451 · Bird Tbird Vela Ventilator · Bird Products Corp. · 2004 · recalledK013642 · AVEA · Bird Products Corp. · 2002 · Class I recallK992788 · Bear Cub 750 PSV · Bear Medical Systems, Inc. · 1999K970839 · Servo Ventilator 300A · Siemens Elema AB · 1997 · recalledK960010 · Servo Ventilator 300 Computer Interface · Siemens Elema AB · 1996K902859 · Servo Ventilator 300 · Siemens Life Support Systems · 1991 · recalled−50
  1. Root · 7 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
  2. 6 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
  3. 5 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
  4. 4 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
  5. 3 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
  6. 2 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
  7. 1 generation backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
  8. This deviceK093261 MOVESThornhill Research, Inc. · 2010
  9. Descendant · cites it directly · 4 of its ownK141460 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2015
  10. Descendant · 2 generations on · 3 of its ownK160967 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2017
  11. Descendant · 2 generations on · 2 of its ownK173916 Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2018
  12. Descendant · cites it directly · 1 of its ownK140049 Moves SLCThornhill Research, Inc. · 2014
  13. Descendant · 3 generations on · 0 of its ownK223332 Task Force CORECnsystems Medizintechnik GmbH · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12017: 22018: 12019: 12023: 1
2014high 2 (2017) · low 0 (2016)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 7 · See all
  • K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2015 · cites it directly4descendants
  • K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2017 · 2 generations on3descendants
  • K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V. · 2018 · 2 generations on2descendants
  • K140049Moves SLCThornhill Research, Inc. · 2014 · cites it directly1descendant
  • K223332Task Force CORECnsystems Medizintechnik GmbH · 2023 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K902859Servo Ventilator 300Siemens Life Support Systems19913
−6K960010Servo Ventilator 300 Computer InterfaceSiemens Elema AB1996—
−5K970839Servo Ventilator 300ASiemens Elema AB19974
−4K992788Bear Cub 750 PSVBear Medical Systems, Inc.1999—
−3K013642AVEABird Products Corp.2002Class I
−2K032451Bird Tbird Vela VentilatorBird Products Corp.20041
−1K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2005—
0 (this device)K093261MOVESThornhill Research, Inc.2010—
+1K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.2015—
+2K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.2017—
+2K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.2018—
+1K140049Moves SLCThornhill Research, Inc.2014—
+3K223332Task Force CORECnsystems Medizintechnik GmbH2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198810
199030
199140
199220
199310
199440
199570
199660
199710
199872
199960
200010
200140
200220
200320
200420
200510
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201720
201810
201910
202310
FIG. 1 — Lineage of K093261, 1991–2023Source: 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.

4 devices in this family have 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 BTL device

  1. #1 K242769 VentStar Resus heated (N) (MP17030); VentStar…score 11.2 · 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? (8)

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
*K013931Omni Oxygen System, Model 1000
Summary page 3
…devices: Device 510(k) t Sequal Eclipse 2 K013931 VersaMed iWent 201 K052554 Univent Eagle 73x…
Sequal Technologies, Inc.20021
*K052554Modification to: Ivent 201 Portable Ventilator
Summary page 3
…510(k) t Sequal Eclipse 2 K013931 VersaMed iWent 201 K052554 Univent Eagle 73x K051476 Umivent Eagle 754…
Versamed Medical Systems, Inc.2005—
*K051476Uni-Vent Model 73X
Summary page 3
…K013931 VersaMed iWent 201 K052554 Univent Eagle 73x K051476 Umivent Eagle 754 K931473 Hi,-O-x80…
Impact Instrumentation, Inc.20051
*K931473Impact Model 753
Summary page 3
…K052554 Univent Eagle 73x K051476 Umivent Eagle 754 K931473 Hi,-O-x80 K030943 Medela Vario 8 & 18…
Impact Instrumentation, Inc.1994—
*K030943Modification to Hiox
Summary page 3
…K051476 Umivent Eagle 754 K931473 Hi,-O-x80 K030943 Medela Vario 8 & 18 K06 1435 Criticare Poet Plus Patient Monitor (Model 8…
Sensor Medics Corp.2003—
*K061435Medela Vario Suction Pumps
Summary page 3
…K931473 Hi,-O-x80 K030943 Medela Vario 8 & 18 K06 1435 Criticare Poet Plus Patient Monitor (Model 8 100) K012059 Welch Allyn Propag Encore…
Medela AG2006—
*K0120598100/8500 Vital Signs Monitor
Summary page 3
…K030943 Medela Vario 8 & 18 K06 1435 Criticare Poet Plus Patient Monitor (Model 8 100) K012059 Welch Allyn Propag Encore K012451 Comparison to Predicate Devices A Compariso…
Criticare Systems, Inc.2001—
*K012451Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246
Summary page 3
…K06 1435 Criticare Poet Plus Patient Monitor (Model 8 100) K012059 Welch Allyn Propag Encore K012451 Comparison to Predicate Devices A Comparison of specifications demonstrates that the MOVES is substantially equivalent to the i…
Welch Allyn Protocol, Inc.2001—
†K081844GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.20084

Also cleared against K013931: 9 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154
K140049Moves SLCThornhill Research, Inc.20141

Has anything in its family been recalled? (4 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 19, 2015Class IZ-0586-2016Component design/selectionBatteries found unresponsive after storage, not recognized by main device, and are perpetually enabled.
Nov 19, 2015Class IZ-0587-2016Component design/selectionBatteries found unresponsive after storage, not recognized by main device, and are perpetually enabled.

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.

  • K013642AVEABird Products Corp. · 2002 · 3 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
  • K981072Esprit VentilatorRespironics, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
  • K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
  • 13 of the 63 ancestors have a recall of any class; 3 have a Class I recall.
  • Of its descendants, K141460 (Finapres Medical Systems B.V., 2015) has gone furthest, with 4 descendants of its own.
  • 9 other devices also cite its predicate K013931.

How does its category compare?

All BTL devices

BTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · BTL

1in 2025

2007: 52008: 42009: 52010: 32011: 22013: 12014: 72015: 12017: 22018: 12019: 12020: 12021: 12023: 12025: 1
2007high 7 (2014) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BTL

203in 2014

2007: 122 days median2008: 198 days median2009: 173 days median2010: 140 days median2014: 203 days median
2007high 203 (2014) · low 122 (2007)2026

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

Recalls per year · BTL

2in 2024

2007: 12011: 12012: 2, 2 Class I2013: 3, 1 Class I2015: 3, 2 Class I2019: 3, 3 Class I2021: 12024: 2, 2 Class I
2007high 3 (2013) · low 0 (2008)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · BTL

165in 2025

2007: 52008: 372009: 692010: 962011: 752012: 1152013: 1032014: 702015: 792016: 802017: 1012018: 1972019: 3412020: 4542021: 5062022: 7552023: 7312024: 6672025: 165
2007high 755 (2022) · low 5 (2007)2025

MAUDE reports naming product code BTL, 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
2007512215
20084198037
20095173069
20103140096
20112—175
20120—2 (2)115
20131—3 (1)103
20147203070
20151—3 (2)79
20160—080
20172—0101
20181—0197
20191—3 (3)341
20201—0454
20211—1506
20220—0755
20231—0731
20240—2 (2)667
20251—0165
20260—0—

What is it indicated for?

The MOVESTM is a portable computer controlled electrically powered transport ventilator intended to provide continuous or intermittent emergency ventilatory support for the care of adults who require mechanical ventilation. The MOVESTM is intended to deliver high inspired oxygen concentrations via the MOVESTM 02 mask to spontaneously breathing patients who require elevated inspired oxygen MOVESTM is intended to be used in a transport or emergency setting…

Read the full statement (196 words)

The MOVESTM is a portable computer controlled electrically powered transport ventilator intended to provide continuous or intermittent emergency ventilatory support for the care of adults who require mechanical ventilation.

The MOVESTM is intended to deliver high inspired oxygen concentrations via the MOVESTM 02 mask to spontaneously breathing patients who require elevated inspired oxygen

MOVESTM is intended to be used in a transport or emergency setting on adult patients who weigh between 40 and 120kg.

MOVESTM provides the following supplemental functions for patients that it is ventilating or to whom it is delivering elevated inspired oxygen:

a. Suction

The MOVESTM suction pump is intended for aspiration and removal of fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system.

b. Supplementary Oxygen

The MOVESTM is intended to provide supplemental oxygen enriched air to patients that require supplemental oxygen.

c. Patient Monitoring

The MOVESTm is intended to monitor physiological parameters of patients and provide these parameters to a health care provider for interpretation in the form of physiological data and system alarms. Physiological data and system alarms will be available to the care provider from the monitor.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K093261: MOVES.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093261

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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