KDF-2.3
FDA 510(k) K894264 · Unimar, Inc.
510(k) numberK894264
Submission
- Device name
- KDF-2.3
- Applicant
- Unimar, Inc.
Wilton, CT, US - Received
- June 20, 1989
- Decision date
- August 15, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HDR – Cap, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5250
- Specialty
- Obstetrics/Gynecology
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| K222969 | FERTI-LILY Conception CupHDR · Traditional | Rosesta Medical BV | 06/23/2023SE |
| K993953 | Oves Cervical CapHDR · Traditional | Veos , Ltd. | 03/21/2000SESU |
| K945131 | Imagyn Intrauterine Insemination DeviceHDR · Traditional | Imagyn Medical, Inc. | 05/15/1995SE |
| K950714 | Cook Insemination CupHDR · Traditional | Cook Urological, Inc. | 05/11/1995SE |
| K902171 | Minispace(Tm) Iui CatheterHDR · Traditional | Pharmacia, Inc. | 10/05/1990SE |
| K902694 | Coaxial Catheter SetHDR · Traditional | Cook Ob/Gyn | 08/28/1990SE |
| K896960 | Intrauterine Insemination CathetersHDR · Traditional | C.R. Bard, Inc. | 06/26/1990SE |
| K900316 | Modified Ham's F-10 Medium and Medium-HepesHDR · Traditional | Irvine Scientific | 04/16/1990SE |
| K900308 | Sperm Select SystemHDR · Traditional | Pharmacia, Inc. | 04/13/1990SE |
More from Pharmacia, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K932432 | Kronner Reinforcing StyletteLKF · Traditional | 04/12/1994SE |
| K920803 | HSG TrayHIB · Traditional | 10/19/1992SEKD |
| K910317 | Uni-Sem(Tm)MFD · Traditional | 05/01/1991SE |
| K904473 | Kronner ManipujectorHES · Traditional | 12/14/1990SE |
| K895659 | Hui Mini-FlexHIG · Traditional | 12/19/1989SE |
| K895403 | Aspirette Endocervical AspiratorHFC · Traditional | 11/29/1989SE |
| K890848 | Cervex-BrushHHT · Traditional | 05/11/1989SE |
| K854415 | Endometrial PipelleHHK · Traditional | 03/13/1986SE |
| K810291 | Sterile/Disposable HSG TrayEYY · Traditional | 03/18/1981SE |
Questions and answers
When was KDF-2.3 cleared by the FDA?
KDF-2.3 (K894264) received a 510(k) decision of Substantially Equivalent on August 15, 1989, 56 days after the submission was received.
What is the product code of K894264?
The FDA product code is HDR – Cap, Cervical, a Class II (moderate risk) device regulated under 21 CFR 884.5250.