510(k) · Cleared
ClearedT-Piece Resuscitator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mercury Medical · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Oct 17, 2014 as substantially equivalent to K092085 (Neoforce Group, Inc., 2009) after a 77-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- Oct 17, 2014
- Review
- 77 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K862830 (1986). 15 ancestors in all, the oldest K801883 (1980). No later device cites it as a predicate yet.
- Root · 5 generations backK862830 Models 2R and 3R Pneupac Ventilator/ResuscitatorPneupac, Ltd. · 1986
- 4 generations backK024344 Pneuton VentilatorAiron Corporation · 2003
- 3 generations backK043085 Modification to: Pneuton VentilatorAiron Corporation · 2004
- 2 generations backK080692 Macs Cpap SystemAiron Corporation · 2008
- 1 generation backK092085 Ispira Resuscitation UnitNeoforce Group, Inc. · 2009
- This deviceK142096 T-Piece ResuscitatorMercury Medical · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K862830 | Models 2R and 3R Pneupac Ventilator/Resuscitator | Pneupac, Ltd. | 1986 | — |
| −4 | K024344 | Pneuton Ventilator | Airon Corporation | 2003 | — |
| −3 | K043085 | Modification to: Pneuton Ventilator | Airon Corporation | 2004 | — |
| −2 | K080692 | Macs Cpap System | Airon Corporation | 2008 | — |
| −1 | K092085 | Ispira Resuscitation Unit | Neoforce Group, Inc. | 2009 | — |
| 0 (this device) | K142096 | T-Piece Resuscitator | Mercury Medical | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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.
Planning a device in BTL? 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092085 | Ispira Resuscitation UnitSummary page 4…ncy ventilator CFR 868.5925 Device: T-Piece Resuscitator Predicate Devices: NeoForce – ISPIRA - K092085 Mercury – NeoTee™ - K093913 Device Description: The Mercury T-Piece Resuscitator is manually op… | 2009 |
| † | K093913 | Mercury Medical T-Piece Resuscitator | 2010 |
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 28 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 15 ancestors has a recall.
- 2 other devices also cite its predicate K092085.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient’s airway. It is intended for use with patients weighing greater than 10kg (>22lb).
Environment of Use – Hospital, sub-acute facilities, and pre-hospital (EMS)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142096 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142096: T-Piece Resuscitator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142096
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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