I.V. Start Kit (AHC-50-54954
FDA 510(k) K924192 · American Healthcare Corp.
510(k) numberK924192
Submission
- Device name
- I.V. Start Kit (AHC-50-54954
- Applicant
- American Healthcare Corp.
South Plainfield, NJ, US - Received
- August 20, 1992
- Decision date
- August 27, 1993
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KGX – Tape And Bandage, Adhesive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5240
- Specialty
- General Hospital
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|---|---|---|---|
| K001240 | Seragard Injection PatchKGX · Traditional | Platinum Services, Inc. | 06/21/2000SE |
| K983368 | Care Band Antibacterial BandagesKGX · Traditional | Aso Corp. | 02/17/1999SE |
| K972914 | Syvek PatchKGX · Traditional | Marine Polymer Technologies, Inc. | 12/22/1997SE |
| K943314 | Adhesive Bandages with OTC DrugKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 01/17/1996SE |
| K952606 | Targett PatchKGX · Traditional | Cutting Edge Technologies, Inc. | 12/21/1995SE |
| K954007 | ParallelKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 11/22/1995SE |
| K944587 | Dermiview Hypoallergenic Clear TapeKGX · Traditional | Johnson & Johnson Medical, Inc. | 10/30/1995SE |
| K944588 | Sterile Plastic DressingKGX · Traditional | Smith & Nephew, Inc. | 11/07/1994SE |
| K941788 | Band-Aid Brand Adhesive Bandages, Sport StripKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 10/03/1994SE |
| K940536 | Band-Aid(Tm) Brand Adhesive BandageKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 10/03/1994SE |
More from Johnson & Johnson Consumer Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K043543 | Blood Glucose Monitoring SystemNBW · Traditional | 04/08/2005SE |
| K043512 | Easygluco IGM-0002 G2CGA · Traditional | 04/08/2005SE |
| K031501 | Easygluco, Model IGM0002NBW · Traditional | 10/16/2003SE |
| K923941 | Irrigation Tray W/ Bulb Syringe & Sterile SalineEYN · Traditional | 06/17/1993SEKD |
| K923940 | Irrigation Tray W/ Piston Syringe & Sterile SalineEYN · Traditional | 06/17/1993SEKD |
| K923939 | Irrigation Tray W/ Bulb Syringe & Sterile WaterEYN · Traditional | 06/17/1993SEKD |
| K923938 | Irrigation Tray W/ Piston Syringe & Sterile WaterEYN · Traditional | 06/17/1993SEKD |
| K924193 | Tracheostomy Care Set W/ Hydro PEROX(AHC-20-54685)BTO · Traditional | 06/16/1993SEKD |
| K924191 | Tracheostomy Care Set with Gloves and Extra TowelBTO · Traditional | 04/02/1993SESK |
| K924195 | Tracheostomy Care Set W/Forceps & Gauze Trach DresBTO · Traditional | 01/06/1993SE |
Questions and answers
When was I.V. Start Kit (AHC-50-54954 cleared by the FDA?
I.V. Start Kit (AHC-50-54954 (K924192) received a 510(k) decision of Unknown on August 27, 1993, 372 days after the submission was received.
What is the product code of K924192?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.