MERCURY MEDICAL T-PIECE RESUSCITATOR— 510(k) K093913
Substantially EquivalentMercury Medical, Inc.
FDA 510(k) clearance K093913 for MERCURY MEDICAL T-PIECE RESUSCITATOR, Substantially Equivalent on 2010-04-06. Applicant: Mercury Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Mercury Medical, Inc.
- Product code
- Code BTL
- Device class
- Class 2
- Regulation
- 21 CFR 868.5925
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bonita Springs, FL, US
Recent devices under product code BTL
view allAdverse events under product code BTL
product code BTL- Death
- 8
- Malfunction
- 3,256
- Other
- 1
- Total
- 3,265
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K093913
K-number listed on FDA's recall record- Z-0821-2025 — Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
- Z-0004-2025 — Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
- Z-0639-2016 — Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee 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 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093913.
Data sourced from openFDA. This site is unofficial and independent of the FDA.