MEDLINE BAND BAGS AND EQUIPMENT COVERS
FDA 510(k) clearance K032065 · decided 2003-09-22
Clearance details
- K-number
- K032065
- Device name
- MEDLINE BAND BAGS AND EQUIPMENT COVERS
- Applicant
- Medline Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-03
- Decision date
- 2003-09-22
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- MMP
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Waukegan, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medline Industries
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN (K091178) | Mtp Medical Technical Promotion GmbH | 2009-07-31 |
| LIGHT DRAPE (K043234) | Wrapped IN Comfort | 2005-05-25 |
| GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS (K041501) | Guangzhou Fortunique , Ltd. | 2004-11-30 |
| INCUBATOR CAPE (K040794) | Wrapped IN Comfort | 2004-06-10 |
| SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 (K023540) | Valumed | 2003-02-04 |
| MEDSURG EQUIPMENT COVERS (K014239) | International Medsurg Connection | 2002-02-19 |
| ULTRASOUND SYSTEMS DRAPE (K970885) | Protek Medical Products, Inc. | 1997-09-22 |
| COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER (K962288) | Pinnacle Products, Inc. | 1997-01-30 |
| EQUIPMENT COVERS (K961699) | United States Surgical, A Division of Tyco Healthc | 1996-08-23 |
| PROTOUCH OVERGLOVE (K952241) | Cottrell, Ltd. | 1995-08-07 |
| STERILE EQUIPMENT COVERS (K931417) | Custom Medical Products, Ltd. | 1995-07-06 |
| SURGICAL MICROSCOPE DRAPE (K944198) | Hydro-Med Products, Inc. | 1994-11-27 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. C recall (Z-2290-2023) | MEDLINE INDUSTRIES, LP - Northfield | 2023-08-03 |
| Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE recall (Z-2154-2023) | MEDLINE INDUSTRIES, LP - Northfield | 2023-07-20 |