SCL · Allergen And Vaccine Delivery Needles
General Hospital · 21 CFR 880.5570 · Class 2
Overview
| Product Code | SCL |
|---|---|
| Device Name | Allergen And Vaccine Delivery Needles |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 25)
Showing 20 most recent of 25 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250983 | Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) | Asistan Medikal | Jan 30, 2026 | SESE |
| K222385 | Bifurcated Needle | Anhui Tiankang Medical Technology Co., Ltd. | Dec 6, 2022 | SESE |
| K182582 | Oryum and Ovem Epidermal Deri Prick Test Applicator | Allergy & Applicator Depot, LLC | Apr 10, 2019 | SESE |
| K172062 | AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray | Medscience Science Research Group, Inc. | Mar 5, 2018 | SESE |
| K162917 | Allerhope Allergy Skin Tester | Procare Industrial Co., Limited | Aug 17, 2017 | SESE |
| K032528 | BD ECLIPSE BIFURCATED NEEDLE | Becton, Dickinson & CO | Sep 9, 2003 | SESE |
| K031630 | BIFURCATED ALLERGY SKIN TESTING NEEDLE | Precision Medical Products, Inc. | Aug 7, 2003 | SESE |
| K020523 | BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 | Bd | Mar 20, 2002 | SESE |
| K020500 | UNIVEC BIFURCATED SLIDING SHEATH SYRINGE | Univec, Inc. | Mar 19, 2002 | SESE |
| K012515 | BIFURCATED VACCINATING NEEDLE | Precision Medical Products, Inc. | Sep 19, 2001 | SESE |
| K011979 | ALLERSHARP ALLERGY SKIN TESTER | Hmb Medical Concepts, Ltd. | Sep 14, 2001 | SESE |
| K003195 | GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC | Greer Laboratories, Inc. | Dec 13, 2000 | SESE |
| K000299 | DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D | Biomedex, Inc. | Apr 28, 2000 | SESE |
| K982578 | QUANTI-TEST SYSTEM | Panatrex, Inc. | Sep 2, 1998 | SESE |
| K961918 | MULTI-TEST II | Lincoln Diagnostics, Inc. | Aug 7, 1996 | SESE |
| K953939 | QUINTEST | Bayer Corp. | Nov 13, 1995 | SESE |
| K941820 | DUOTIP-TEST | Lincoln Diagnostics, Inc. | Sep 2, 1994 | SESE |
| K922177 | DISPOSABLE MULTI-PUNCTURE APPLICATOR | Allergy Extract Co. | Jun 17, 1993 | SESE |
| K890360 | GREER DERMAPIK SYSTEM | Greer Laboratories, Inc. | Jun 23, 1989 | SESE |
| K882360 | DERMAPIK | Creative Scientific Equipment Corp. | Aug 9, 1988 | SESE |
Top Applicants
- Greer Laboratories, Inc. — 2 clearances
- Lincoln Diagnostics, Inc. — 2 clearances
- Precision Medical Products, Inc. — 2 clearances
- Aller-Screen, Inc. — 1 clearance
- Aller/Guard, Inc. — 1 clearance
