510(k) · Cleared
Recalled · Class I · 2024Mercury Medical T-Piece Resuscitator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mercury Medical, Inc. · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Apr 6, 2010 as substantially equivalent to K070210 (Ohmeda Medical, 2007) and 1 other predicate after a 105-day review. Its family tree reaches back 3 generations to 1976. 2 of the 10 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 3 times, including 2 Class I recalls.
- Decided
- Apr 6, 2010
- Review
- 105 days
- Class
- Class II
- Product code
- BTL
- Recalls
- 3 (2 Class I)
- Predicates
- 2
Its longest line of descent runs back 3 generations to K760102 (1976). 8 ancestors in all. 1 later device descends from it, 1 citing it directly. 2 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK760102 Flowmeter, P.C., Redesigned VersionOhio Medical Products · 1976
- 2 generations backK971243 Ohmeda Infant Resuscitation SystemOhmeda Medical · 1997
- 1 generation backK070210 Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · Recalled (Class I)
- This deviceK093913 Mercury Medical T-Piece ResuscitatorMercury Medical, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK173373 SafeT T-Piece ResuscitatorVentlab, LLC · 2018
Class I recalls in this family
- K070210 Giraffe and Panda T- Piece Resuscitation Systemdirect predicate · 2007
Most influential descendants
Showing 1 of 1 · See all- K173373SafeT T-Piece ResuscitatorVentlab, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K760102 | Flowmeter, P.C., Redesigned Version | Ohio Medical Products | 1976 | — |
| −2 | K971243 | Ohmeda Infant Resuscitation System | Ohmeda Medical | 1997 | — |
| −1 | K070210 | Giraffe and Panda T- Piece Resuscitation System | Ohmeda Medical | 2007 | Class I |
| 0 (this device) | K093913 | Mercury Medical T-Piece Resuscitator | Mercury Medical, Inc. | 2010 | — |
| +1 | K173373 | SafeT T-Piece Resuscitator | Ventlab, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K070210 | Giraffe and Panda T- Piece Resuscitation SystemSummary page 5…cate devices because: Indications - * Similar to predicate -F&P -NeoPuff-K1892885 Technology - * Similar technology and design - o GE Giraffe-K070210 and F&P-NeoPuff--K1892885 Materials - * The materials in patient contact are identical to predicate devices manufactured by… | 2007 |
| * | K892885 | Resubmitted RD1000 Neopuff Infant ResuscitatorSummary page 1…Mercury Medical T-Piece Resuscitator Predicate Devices: GE - Giraffe and Panda - K07021IO Fisher & Paykel - NeoPuff - K892885 Device Description: The Mercury Medical T-Piece Resuscitator (Neo-Teerh) is a gas power resuscitator for use with neonates / infa… | 1989 |
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 |
|---|---|---|---|
| K173373 | SafeT T-Piece Resuscitator | 2018 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 10, 2024 | Class I | Z-0821-2025 | Process change control | Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive… |
| Aug 30, 2024 | Class I | Z-0004-2025 | Process control | Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step. |
| Oct 22, 2015 | Class II | Z-0639-2016 | Device Design | Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient. |
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.
- K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- 2 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K173373 (Ventlab, LLC, 2018) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K070210.
How does its category compare?
All BTL devicesBTL 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
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 Neo-TeeTm 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 neonates and infants weighing less than I10kg (22 lb).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093913 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093913: Mercury Medical T-Piece Resuscitator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093913
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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