Sterile Water and 0.9% Sodium Chloride for Irrigation, Usp
FDA 510(k) K994321 · Automatic Liquid Packaging, Inc.
510(k) numberK994321
Submission
- Device name
- Sterile Water and 0.9% Sodium Chloride for Irrigation, Usp
- Applicant
- Automatic Liquid Packaging, Inc.
Woodstock, IL, US - Received
- December 22, 1999
- Decision date
- October 25, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOL – Catheter And Tip, Suction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code JOL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K051370 | Sterile Saline for Device Care, Sterile Water for Device Care, Models 2F7121, 2F8014JOL · Traditional | Baxter Healthcare Corp | 08/12/2005SE |
| K000266 | Primary Care Solutions Sterile SALINE-0.9% Sodium Chloride for Device IrrigationJOL · Traditional | Primary Care Solutions, Inc. | 07/12/2001SE |
| K000265 | Primary Care Solutions Sterile Water Device IrrigationJOL · Traditional | Primary Care Solutions, Inc. | 07/12/2001SE |
| K003402 | Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device…JOL · Traditional | Welcon, Inc. | 05/01/2001SE |
| K974759 | Hydrox Saline Solution 0.9% Sodium Chloride 4 Oz. Cup 120 ML 100 ML BottleJOL · Traditional | Hydrox Laboratories | 03/09/1998SE |
| K974758 | Hydrox Sterile Water 4 Oz. Cup 120 Ml., Hydrox Sterile Water 100 ML BottleJOL · Traditional | Hydrox Laboratories | 03/09/1998SE |
| K974397 | Sterile Saline for Catheter CareJOL · Traditional | Baxter Healthcare Corp | 02/10/1998SE |
| K973734 | Sterile Water for Device Irrigation/ Sterile Saline for Device IrrigationJOL · Traditional | Welcon, Inc. | 02/05/1998SE |
| K972372 | Germ Trapper Suction Tube HolderJOL · Traditional | Rzv Medical Specialties, Inc. | 12/11/1997SE |
| K960216 | CPR Suction Catheter KitJOL · Traditional | Custom Pack Reliability | 04/15/1996SE |
More from Custom Pack Reliability
| 510(k) | Device | Decision |
|---|---|---|
| K000964 | Sterile Water or O.9% Sodium Chloride, Model AL4100 & AL4109JOH · Special | 04/25/2000SE |
| K980147 | Your Choice Multi-Purpose Contact Lens Cleaning SolutionLPN · Traditional | 04/13/1998SE |
| K973829 | Irrigation BottleJOH · Traditional | 02/23/1998SE |
| K962079 | Humidifier AdapterBTT · Traditional | 07/31/1996SE |
| K955104 | High Flow Adjustable Entrainment NebulizerCAF · Traditional | 06/11/1996SE |
| K920306 | Opti-Mol Filtered Puncture PinBTT · Traditional | 04/06/1992SE |
| K911770 | Optimol Respiratory Humidification SystemBTT · Traditional | 10/15/1991SE |
| K901762 | Prefilled Flexible R.T. Containers W/Ster. SodiumBTT · Traditional | 07/17/1990SE |
| K901362 | Accessory Fitment to Nebulizer System, SterileCAF · Traditional | 06/06/1990SE |
| K901301 | Ster Inhal Solut Prefil BTL W/Adjust Entrain NebulCAF · Traditional | 05/31/1990SE |
Questions and answers
When was Sterile Water and 0.9% Sodium Chloride for Irrigation, Usp cleared by the FDA?
Sterile Water and 0.9% Sodium Chloride for Irrigation, Usp (K994321) received a 510(k) decision of Substantially Equivalent on October 25, 2000, 308 days after the submission was received.
What is the product code of K994321?
The FDA product code is JOL – Catheter And Tip, Suction, a Class II (moderate risk) device regulated under 21 CFR 880.6740.