Nonrebreathing Circuit
FDA 510(k) K882285 · Dryden Corp.
510(k) numberK882285
Submission
- Device name
- Nonrebreathing Circuit
- Applicant
- Dryden Corp.
Indianapolis, IN, US - Received
- June 1, 1988
- Decision date
- August 16, 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
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| K212905 | Sotair DeviceBTM · Traditional | Safe Bvm Corporation | 08/18/2022SE |
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| 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 |
|---|---|---|
| K880923 | Patient Ventilator IsolatorCBK · Traditional | 09/06/1988SE |
| K880769 | Breathing Circuit W/Heated WireBZE · Traditional | 08/24/1988SE |
| K873928 | Universal TourniquetGAX · Traditional | 10/23/1987SE |
| K873927 | Reuseable Breathing TubesBZO · Traditional | 10/20/1987SE |
| K870859 | Bag-Tail Bleed ValveCAI · Traditional | 08/03/1987SE |
| K871386 | Breathing CircuitCAI · Traditional | 05/29/1987SE |
| K870858 | Badgwell Sampling CatheterCCK · Traditional | 05/14/1987SE |
| K861540 | Disposable Berman and Guedel AirwaysCAE · Traditional | 05/02/1986SE |
| K850644 | Nasopharyngeal Airway-RobertazziBTQ · Traditional | 03/21/1985SE |
| K842843 | Dryden Scavenger Interface System · Traditional | 07/27/1984SE |
Questions and answers
When was Nonrebreathing Circuit cleared by the FDA?
Nonrebreathing Circuit (K882285) received a 510(k) decision of Substantially Equivalent on August 16, 1988, 76 days after the submission was received.
What is the product code of K882285?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.