OneTouch Delica Plus Lancing System
K221546 is the FDA 510(k) clearance record for OneTouch Delica Plus Lancing System, a class II device, cleared for Asahi Polyslider Co., Ltd. on under FDA product code QRL (Multiple Use Blood Lancet For Single Patient Use Only). FDA's definition for product code QRL reads: "A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes". FDA records list 2 510(k) clearances for Asahi Polyslider Co., Ltd., from to . As of , FDA records show no recalls naming K221546.
Clearance record
- Decision date
- Received
- (88 days to decision)
- Product code
- QRL Multiple Use Blood Lancet For Single Patient Use Only
- Regulation
- 21 CFR 878.4850
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Applicant
- Asahi Polyslider Co., Ltd. 860-2 Misaki, Maniwa, JP
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code QRL
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 1 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 2 |
| August 2026 | 1 |
| September 2026 | 0 |
| October 2026 | 0 |
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