510(k) · Cleared
Recalled · Class I · 2019O-Two E700,O-Two E600,O-Two E500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O-Two Medical Technologies, Inc. · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Mar 16, 2015 as substantially equivalent to K062267 (Drager Medical B.V., 2006) and 1 other predicate after a 276-day review. Its family tree reaches back 6 generations to 1997. 2 of the 25 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 3 times, including 3 Class I recalls.
- Decided
- Mar 16, 2015
- Review
- 276 days
- Class
- Class II
- Product code
- BTL
- Recalls
- 3 (3 Class I)
- Predicates
- 2
Its longest line of descent runs back 6 generations to K962603 (1997). 23 ancestors in all, the oldest K860555 (1986). 1 later device descends from it, 1 citing it directly. 2 of the 25 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 4 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 3 generations backK021981 Ivent 201 Portable VentilatorVersamed, Ltd. · 2003
- 2 generations backK042468 Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2004
- 1 generation backK062267 Oxylog 3000Drager Medical B.V. · 2006 · Recalled (Class I)
- This deviceK141595 O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK221634 Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/A · 2023
Class I recalls in this family
- K062267 Oxylog 3000direct predicate · 2006
Most influential descendants
Showing 1 of 1 · See all- K221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/A · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −5 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −4 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −3 | K021981 | Ivent 201 Portable Ventilator | Versamed, Ltd. | 2003 | — |
| −2 | K042468 | Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2004 | — |
| −1 | K062267 | Oxylog 3000 | Drager Medical B.V. | 2006 | Class I |
| 0 (this device) | K141595 | O-Two E700,O-Two E600,O-Two E500 | O-Two Medical Technologies, Inc. | 2015 | — |
| +1 | K221634 | Oxymag - Transport and Emergency Ventilator | Magnamed Tecnologia Medica S/A | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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.
2 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 K242769 VentStar Resus heated (N) (MP17030); VentStar…score 11.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062267 | Oxylog 3000Summary page 4…esiology Predicate Devices: Oxylog 3000 Manufactured Draeger medical GmbH 510(k) number K062267 Carevent PAR Manufactured by O-Two Medical Technologies Inc.… | 2006 |
| * | K081330 | Carevent Par (Public Access Resuscitator)Summary page 4…Carevent PAR Manufactured by O-Two Medical Technologies Inc. 510(k) number K081330 Device Description: The proposed o_two e700, o_two e600 and o_two e500 are time-cycled, volume-constant and pressure controlle… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221634 | Oxymag - Transport and Emergency Ventilator | 2023 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 12, 2019 | Class I | Z-0976-2019 | Process control | There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main… |
| Feb 12, 2019 | Class I | Z-0978-2019 | Process control | There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main… |
| Feb 12, 2019 | Class I | Z-0977-2019 | Process control | There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main… |
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.
- K062267Oxylog 3000Drager Medical B.V. · 2006 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 23 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K221634 (Magnamed Tecnologia Medica S/A, 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K062267.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · BTL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTL
203in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTL
2in 2024
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · BTL
165in 2025
MAUDE reports naming product code BTL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 122 | 1 | 5 |
| 2008 | 4 | 198 | 0 | 37 |
| 2009 | 5 | 173 | 0 | 69 |
| 2010 | 3 | 140 | 0 | 96 |
| 2011 | 2 | — | 1 | 75 |
| 2012 | 0 | — | 2 (2) | 115 |
| 2013 | 1 | — | 3 (1) | 103 |
| 2014 | 7 | 203 | 0 | 70 |
| 2015 | 1 | — | 3 (2) | 79 |
| 2016 | 0 | — | 0 | 80 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 1 | — | 0 | 197 |
| 2019 | 1 | — | 3 (3) | 341 |
| 2020 | 1 | — | 0 | 454 |
| 2021 | 1 | — | 1 | 506 |
| 2022 | 0 | — | 0 | 755 |
| 2023 | 1 | — | 0 | 731 |
| 2024 | 0 | — | 2 (2) | 667 |
| 2025 | 1 | — | 0 | 165 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
o_two e700, e600 and e500 are a time-cycled, volume-constant and pressure-controlled (only e700) emergency and
transport ventilator designed for use in the pre-hospital, intra-hospital, inter-hospital and transport settings. It is intended
for use with adult, child, infant patients with a tidal volume from 50 ml (100 ml for e500) upwards who are in respiratory
and/or cardiac arrest or respiratory distress and who require ventilatory support.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141595: O-Two E700,O-Two E600,O-Two E500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141595
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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