1ST Response (TM) Infant Manual Resuscitator
FDA 510(k) K902733 · Intertech Resources, Inc.
510(k) numberK902733
Submission
- Device name
- 1ST Response (TM) Infant Manual Resuscitator
- Applicant
- Intertech Resources, Inc.
Fort Myers, FL, US - Received
- June 21, 1990
- Decision date
- August 22, 1990
- 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 |
|---|---|---|
| K961318 | 1ST Response Disposable ManometerCAP · Traditional | 12/17/1996SE |
| K955008 | Heat & Moisture ExchangerBYD · Traditional | 01/30/1996SE |
| K953580 | Heat Moisture ExchangerBYD · Traditional | 09/15/1995SE |
| K952223 | Xenon Gas Breathing CircuitIYT · Traditional | 08/11/1995SE |
| K952214 | Sims Intertech Hyperinflation Bag SystemNHK · Traditional | 06/08/1995SE |
| K952169 | Safe Response Mouth-To-Mask Resuscitator, PediatricBTM · Traditional | 06/08/1995SE |
| K952062 | PFT FilterCAH · Traditional | 06/08/1995SE |
| K935036 | Hepa Filtered Heat and Moisture ExchangerBYD · Traditional | 01/25/1994SESK |
| K930816 | Hepa Filtered HmeCAH · Traditional | 07/01/1993SE |
| K922479 | Disposable Anesthesia Breathing Circuit, ModifiedBZO · Traditional | 10/30/1992SE |
Questions and answers
When was 1ST Response (TM) Infant Manual Resuscitator cleared by the FDA?
1ST Response (TM) Infant Manual Resuscitator (K902733) received a 510(k) decision of Substantially Equivalent on August 22, 1990, 62 days after the submission was received.
What is the product code of K902733?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.