Pint Bottle Well
FDA 510(k) K781364 · Baxa Corp., Sub. of Cook Group, Inc.
510(k) numberK781364
Submission
- Device name
- Pint Bottle Well
- Applicant
- Baxa Corp., Sub. of Cook Group, Inc.
Mchenry, IL, US - Received
- August 7, 1978
- Decision date
- October 17, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KYX – Dispenser, Liquid Medication
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6430
- Specialty
- General Hospital
Other 510(k)s with product code KYX
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| K143177 | KleenGel DispenserKYX · Traditional | Kleengel, LLC | 09/14/2015SE |
| K980109 | Cyclotech Cyclosporine Oral Solutions DispenserKYX · Traditional | Sangstat Medical Corp. | 08/18/1998SE |
| K954181 | Canyons Bi-Directional Check ValveKYX · Traditional | Canyon Medical Products | 11/29/1995SE |
| K830571 | Bottle AdapterKYX · Traditional | Burron Medical Products, Inc. | 03/24/1983SE |
| K801008 | Multi-Ad Fluid Dispensing Pump MP-3000KYX · Traditional | Burron Medical Products, Inc. | 06/02/1980SE |
| K800437 | Syringe Tip ConnectorKYX · Traditional | Burron Medical Products, Inc. | 03/12/1980SE |
| K800362 | Fluid Dispensing SystemKYX · Traditional | Pharmaseal Laboratories | 03/12/1980SE |
| K792227 | Multi-Ad Fluid Dispensing SystemKYX · Traditional | National Patent Development Corp. | 12/20/1979SE |
| K771539 | StepperKYX · Traditional | Tridak | 10/07/1977SE |
| K760517 | Cup, Disposable MedicineKYX · Traditional | Landmark Plastics | 11/12/1976SE |
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|---|---|---|
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| K904225 | KwikmixLHI · Traditional | 11/05/1990SE |
| K900585 | Tubing Sets for Baxa Exacta-Med Pharmacy PumpLHI · Traditional | 04/18/1990SE |
| K873875 | Baxa Exacta-Med Pharmacy PumpFRN · Traditional | 11/24/1987SE |
| K872743 | Baxa Tubing Sets (for Pharmacy Pump)FMF · Traditional | 10/09/1987SE |
| K844904 | Cytosafe NeedleLHI · Traditional | 02/22/1985SE |
| K832347 | Twofer NeedleLHI · Traditional | 09/12/1983SE |
| K832332 | Vented I.V. Transfer NeedleLHI · Traditional | 09/12/1983SE |
| K832312 | I.V. Transfer NeedleLHI · Traditional | 09/12/1983SE |
Questions and answers
When was Pint Bottle Well cleared by the FDA?
Pint Bottle Well (K781364) received a 510(k) decision of Substantially Equivalent on October 17, 1978, 71 days after the submission was received.
What is the product code of K781364?
The FDA product code is KYX – Dispenser, Liquid Medication, a Class I (low risk) device regulated under 21 CFR 880.6430.