510(k) K810075
- Device
- AUTOCLIX
- Applicant
- BIODYNAMICS CORP.
- 510(k) number
- K810075
- Product code
- FMK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-02-04
- Date received
- 1981-01-13
- Regulation
- 878.4800
- Classification name
- Lancet, Blood
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3009109626
- 1066444
- 3034603279
- 3001452053
- 3016096098
- 3008382007
- 3013496867
- 9617475
- 3003902721
- 3030446844
- 3002807315
- 3026211706
- 3006899020
- 3021314645
- 3043534762
- 3012680643
- 9613304
- 8021764
- 3043226252
- 3015140199
- 3007384659
- 3008337059
- 3005280205
- 3015142721
- 3004525100
- 1058584
- 3005271071
- 3039524238
- 3027529701
- 3008789114
- 3013226
- 3013019728
- 3012172036
- 3031259044
- 3002807408
- 3007441619
- 3010194621
- 3012448339
- 3012677227
- 3010132111
- 3030186688
- 3020976354
- 3022147580
- 1721183
- 3038184658
- 3011369203
- 3006446479
- 3002808145
- 3015485283
- 3004513970
- 3010041511
- 3013557562
- 3002807112
- 3031233007
- 2243072
- 3021169869
- 3014649053
- 3007740684
- 2531491
- 3010131137
- 3009498536
- 3014312726
- 3038610665
- 1722458
- 3030747802
- 1217183
- 3007185216
- 3006210673
- 3008700497
- 3008102042
- 3015058854
- 3004143450
- 3009171251
- 3030896267
- 3044026004
- 3014579161
- 3003723176
- 3017923561
- 3007134734
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FMK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262526 | Safety lancet (XL) | Tianjin Huahong Technology Co., Ltd. | 2026-09-13 |
| K261045 | Verifine Safety Lancets | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-01 |
| K260191 | Safety lancet (XXXVII) | Tianjin Huahong Technology Co., Ltd. | 2026-03-31 |
| K253605 | Safety Heel Lancet | Ningbo Medsun Medical Co., Ltd. | 2026-02-20 |
| K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) | Tianjin Huahong Technology Co., Ltd. | 2026-02-12 |
| K251694 | safety lancet | Tianjin Huahong Technology Co., Ltd. | 2025-06-26 |
| K244036 | Heel Incision Safety Lancet (SteriHeel 2) | SteriLance Medical (Suzhou), Inc. | 2025-02-26 |
| K242680 | LetsGetChecked Impress | Privapath Diagnostics Ltd (Dba Letsgetchecked) | 2025-01-13 |
| K243533 | Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus | Hlb Co., Ltd. Healthcare | 2025-01-13 |
| K242664 | gentleheel® Adult Incision Device | Gri-Alleset, Inc. | 2024-11-05 |
| K242627 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | 2024-10-30 |
| K242316 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | 2024-08-28 |
| K241848 | MedtFine Safety Lancet | Ningbo Caremed Medical Products Co., Ltd. | 2024-08-20 |
| K241750 | Medifun Safety Lancet ( MSL1 series) | Medifun Corporation | 2024-08-15 |
| K241627 | Safety Lancet (XXXV) | Tianjin Huahong Technology Co., Ltd. | 2024-06-20 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases