Lifeguard Single Use Manual Resuscitators
FDA 510(k) K881087 · Lifeguard Medical Products, Inc.
510(k) numberK881087
Submission
- Device name
- Lifeguard Single Use Manual Resuscitators
- Applicant
- Lifeguard Medical Products, Inc.
Indianapolis, IN, US - Received
- March 14, 1988
- Decision date
- April 14, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTM – Ventilator, Emergency, Manual (Resuscitator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5915
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BTM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251631 | The BAG manual resuscitator and accessoriesBTM · Traditional | Laerdal Medical AS | 11/24/2025SE |
| K243861 | butterflyBVMBTM · Traditional | Compact Medical, Inc. | 04/25/2025SE |
| K221841 | EOlife®BTM · Traditional | Archeon | 03/18/2023SE |
| K212905 | Sotair DeviceBTM · Traditional | Safe Bvm Corporation | 08/18/2022SE |
| K210288 | Disposable Manual ResuscitatorBTM · Traditional | Xiamen Compower Medical Tech. Co., Ltd. | 08/26/2021SE |
| K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator…BTM · Traditional | Flexicare Medical Limited. | 12/07/2018SE |
| K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount…BTM · Traditional | Foremount Enterprise Co., Ltd. | 05/11/2018SE |
| K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II…BTM · Abbreviated | Ambu A/S | 08/29/2016SE |
| K132172 | Neonatalie ResuscitatorBTM · Abbreviated | Laerdal Medical A/S | 01/15/2015SE |
| K112852 | Babi Plus Neonatal Resuscitation BagBTM · Traditional | A Plus Medical | 01/13/2012SE |
More from A Plus Medical
| 510(k) | Device | Decision |
|---|---|---|
| K013421 | Lifeguard Nasal CPAP Mask and AccessoriesBZD · Traditional | 01/08/2002SE |
| K915296 | Monopolar ElectrodeGEI · Traditional | 09/03/1992SE |
| K920471 | Levy Articulating RetractorGAD · Traditional | 06/23/1992SE |
| K915505 | Regulator FlowmeterCAN · Traditional | 04/22/1992SE |
| K915297 | Trocar & Trocar Sleeeve 11MM, 10MM, 8MM & 5MMHET · Traditional | 02/11/1992SE |
| K915298 | Suction/Irrigation Cannula; Catlog #532.00GCJ · Traditional | 01/23/1992SE |
| K880958 | Lifeguard Bacterial and Viral FilterCAH · Traditional | 04/27/1988SE |
| K881086 | Lifeguard Mouth to Mask ResuscitatorBTM · Traditional | 04/14/1988SE |
| K880959 | Lifeguard Gas Sampling Line for Mass SpectrometryBZO · Traditional | 04/14/1988SE |
| K863711 | Regulator Oxygen MechanicalCAN · Traditional | 01/27/1987SE |
Questions and answers
When was Lifeguard Single Use Manual Resuscitators cleared by the FDA?
Lifeguard Single Use Manual Resuscitators (K881087) received a 510(k) decision of Substantially Equivalent on April 14, 1988, 31 days after the submission was received.
What is the product code of K881087?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.