Submission Details
| 510(k) Number | K211634 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 27, 2021 |
| Decision Date | August 26, 2021 |
| Days to Decision | 91 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
Hypodermic Needle-Pro EDGE Safety Device
Aug 2021
Decision
91d
Days
Class 2
Risk
About This 510(k) Submission
K211634 is an FDA 510(k) clearance for the Hypodermic Needle-Pro EDGE Safety Device, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Smiths Medical Asd, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 26, 2021, 91 days after receiving the submission on May 27, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.
Device Classification
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
Manufacturer
Similar Devices — FMI Needle, Hypodermic, Single Lumen
All 684
K252886 · Hh Global Technology, Inc.
· Jan 2026
K250700 · Terumo Corporation
· Nov 2025
K252631 · CMT Health PTE., Ltd.
· Oct 2025
K250724 · Spectrum Vascular
· Jul 2025
K250284 · Tsk Laboratory, Japan
· Jul 2025
K251447 · Terumo Europe N.V.
· Jul 2025
More from Smiths Medical Asd, Inc.
View all
K232943
· QNQ · May 2024
K210833
· JOH · Nov 2021
K192375
· FPA · Sep 2020
K181699
· DWJ · Jul 2018
K172800
· MIA · Jun 2018