Instant 20s Indicator
FDA 510(k) clearance K210481 · decided 2021-12-14
Clearance details
- K-number
- K210481
- Device name
- Instant 20s Indicator
- Applicant
- True Indicating, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-02-19
- Decision date
- 2021-12-14
- Days to decision
- 298 days
- Clearance type
- Traditional
- Product code
- MTC
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Toledo, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SPORTROL RAPID STERILITY INDICATOR (K962649) | North American Science Assoc., Inc. | 1997-09-26 |
Recalls involving this device
No recalls on record reference this clearance.