Simplify Compact Resuscitator
by Polymed (Xiamen) Plastic Industrial Co., Ltd.
510(k) K021716
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK021716 | Date8 Oct 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BTM
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5915
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Simplify Compact Resuscitator is a manual bag-valve-mask resuscitator designed for emergency positive pressure ventilation. Classified as a ventilator under FDA’s emergency resuscitation category, it delivers controlled breaths to patients in critical care or transport settings. The device operates via a manual bag and valve assembly, requiring clinician or trained personnel to administer ventilation.
Supplied as a single-use device, the Simplify Compact Resuscitator is intended for use in clinical environments where immediate respiratory support is required. It is regulated under FDA’s 510(k) pathway (K021716) with a classification of Class II (BTM product code). No MRI safety or reusable specifications are noted in the regulatory data. Storage and handling follow standard sterile medical device protocols for single-use resuscitation equipment.
Questions
AI-generated answers, 20 Sep 2026
What clinical scenarios is the Simplify Compact Resuscitator designed for, and who should operate it?
The Simplify Compact Resuscitator is specifically designed for emergency positive pressure ventilation in critical care or transport settings where immediate respiratory support is required. It is intended for use by trained clinicians or personnel who administer ventilation manually via the bag-valve-mask assembly. This makes it suitable for situations like cardiac arrest, respiratory failure, or pre-hospital emergencies where mechanical ventilation is temporarily needed.
Is the Simplify Compact Resuscitator reusable, or is it meant for single-use only?
The Simplify Compact Resuscitator is explicitly supplied as a single-use device. This aligns with standard sterile medical device protocols for resuscitation equipment, ensuring patient safety and hygiene by preventing cross-contamination between uses.
How is the Simplify Compact Resuscitator regulated, and what does that mean for purchasing or clinical use?
The device is regulated under the FDA’s 510(k) pathway (K021716) and classified as a Class II medical device under the BTM (Bag-Type Manual Resuscitators) product code. This means it has undergone a premarket notification review to demonstrate substantial equivalence to a predicate device, ensuring it meets FDA safety and performance standards for emergency resuscitation equipment. Clinicians and buyers can rely on this regulatory pathway as evidence of its compliance with U.S. medical device regulations.
Are there different sizes or models available for the Simplify Compact Resuscitator, and how would I know which one to select?
The provided data does not specify distinct sizes or models for the Simplify Compact Resuscitator, but it is listed under multiple registration numbers, which may correspond to variations in packaging or minor design iterations. Since it is a manual bag-valve-mask resuscitator, selection typically depends on patient age (e.g., pediatric vs. adult) and clinical workflow needs. Consulting the manufacturer’s documentation or a medical supply specialist would help determine the most appropriate option for your specific use case.
What storage and handling guidelines should be followed for the Simplify Compact Resuscitator?
As a single-use device, the Simplify Compact Resuscitator should be stored in accordance with standard sterile medical device protocols. This includes keeping it in its original, unopened packaging until use, protecting it from contamination, and adhering to manufacturer-recommended shelf-life guidelines. Proper storage ensures sterility and functionality, which is critical for emergency resuscitation scenarios.