MERIDIAN MEDICAL SYSTEMS BREATHING FILTER
FDA 510(k) clearance K925217 · decided 1993-01-26
Clearance details
- K-number
- K925217
- Device name
- MERIDIAN MEDICAL SYSTEMS BREATHING FILTER
- Applicant
- Merit Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-10-16
- Decision date
- 1993-01-26
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- CAH
- Device class
- 2
- Regulation number
- 868.5260
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230 recall (Z-0449-2026) | Medline Industries, LP | 2025-11-13 |
| Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008; 2) ANES CIRCUI recall (Z-3031-2024) | MEDLINE INDUSTRIES, LP - Northfield | 2024-09-06 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023/S004) | Merit Medical Systems, Inc. | 2025-12-11 |
| WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S001) | Merit Medical Systems, Inc. | 2025-02-12 |
| WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S002) | Merit Medical Systems, Inc. | 2025-02-12 |
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023) | Merit Medical Systems, Inc. | 2024-12-19 |