bite away neo
FDA 510(k) clearance K220514 · decided 2022-06-23
Clearance details
- K-number
- K220514
- Device name
- bite away neo
- Applicant
- mibeTec GmbH
- Decision
- Substantially Equivalent
- Date received
- 2022-02-22
- Decision date
- 2022-06-23
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- IRT
- Device class
- 2
- Regulation number
- 890.5740
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Brehna, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch mibeTec GmbH
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 |
|---|---|---|
| bite away two (K250047) | mibeTec GmbH | 2025-09-12 |
| Bite Away (K160943) | Riemser Pharma | 2016-08-26 |
| Heated Eye Pad (K142228) | Digital Heat Corporation | 2015-02-09 |
| AVACEN 100 (K133981) | Avacen, Inc. | 2014-08-15 |
| FIR HEAT THERAPHY SYSYEMS (K111273) | Shenzhen Anpan Technology Co., Ltd. | 2011-11-08 |
| BIO-MAT 2000 (K072534) | Richway Intl., Inc. | 2008-02-08 |
| PT-PAC PORTABLE HEATING PAD (K963887) | Anthony A. Chiurco | 1997-03-31 |
| LI'S ITCH STOPPER (K963824) | Hontech Foundation For Medical Technology | 1996-12-12 |
| HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3 (K962195) | Sunbeam Health Division | 1996-11-27 |
| HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 (K962252) | Sunbeam Health Division | 1996-11-25 |
| PES HOT/COLD COMPRESS (K962038) | Princeton Electronic Systems, Inc. | 1996-11-13 |
| FEMININE HEAT WRAP (K924970) | Conair Corp. | 1994-10-03 |
Recalls involving this device
No recalls on record reference this clearance.