Pneumothorax Kit, Motification
510(k) K892640
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK892640 | Date11 Oct 1989 | 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- Withdrawn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
- JDL
- Device Class
- Class III
- Regulation
- 21 CFR Part 888.3320
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Pneumothorax Kit, Motification is a medical device designed for the drainage and re-expansion of the lung in cases of minor pneumothorax. It includes components such as a radiopaque catheter, injection needles, and a blunt fill needle to facilitate the procedure. The kit aids in restoring lung function by removing trapped air from the pleural space.
This kit is supplied sterile and intended for single-use. It is classified under the FDA’s 510(k) pathway with a traditional clearance process, filed under the Orthopedic advisory committee. The components include an 8 French (Fr) x 6.44-inch (16 cm) radiopaque catheter over an 18-gauge (Ga) RW pneumothorax needle, along with 22 Ga and 25 Ga injection needles, and an 18 Ga blunt fill needle. The kit is regulated under FDA regulation number 888.3320 and is intended for use in clinical settings where lung re-expansion is required.
Other devices from Arrow Intl., Inc.
Questions
AI-generated answers, 20 Sep 2026
What is the primary purpose of the Pneumothorax Kit, Motification, and how does it work?
The Pneumothorax Kit, Motification is designed specifically for draining trapped air from the pleural space to restore lung function in cases of minor pneumothorax. It includes a radiopaque catheter (8 French x 16 cm), an 18-gauge RW pneumothorax needle, and additional needles (22 Ga and 25 Ga injection needles, plus an 18 Ga blunt fill needle) to facilitate the procedure. By removing air, the kit helps re-expand the lung, improving respiratory function.
Is this kit intended for single-use or repeated use, and how should it be stored?
The Pneumothorax Kit, Motification is supplied sterile and explicitly intended for single-use only. Since it is sterile, it should be stored in a clean, dry environment, protected from contamination, and kept within the manufacturer’s recommended shelf-life to ensure sterility and functionality.
What sizes and components are included in the kit, and why is the catheter radiopaque?
The kit includes an 8 French x 16 cm radiopaque catheter (paired with an 18-gauge RW needle), along with 22-gauge and 25-gauge injection needles and an 18-gauge blunt fill needle. The catheter is radiopaque to ensure visibility under fluoroscopy or X-ray during placement, reducing the risk of misplacement and improving procedural accuracy.
How was this device’s regulatory pathway determined, and what does that mean for clinicians?
The kit was cleared through the FDA’s 510(k) pathway with a traditional clearance process, filed under the Orthopedic advisory committee (OR). This means it was deemed substantially equivalent to a legally marketed device, ensuring it meets FDA safety and effectiveness standards. Clinicians can rely on its regulatory review as part of their decision-making for treating minor pneumothorax.