Unscented Menstrual Pads-Maxi Pads
FDA 510(k) K813251 · I.C.D. Industries, Inc.
510(k) numberK813251
Submission
- Device name
- Unscented Menstrual Pads-Maxi Pads
- Applicant
- I.C.D. Industries, Inc.
Mchenry, IL, US - Received
- November 19, 1981
- Decision date
- December 14, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HHD – Pad, Menstrual, Unscented
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.5435
- Specialty
- Obstetrics/Gynecology
An unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and synthetic material with an established safety profile.
Other 510(k)s with product code HHD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K071827 | Always Menstrual PadsHHD · Traditional | Procter & Gamble, Inc. | 09/20/2007SE |
| K012629 | Always DuetsHHD · Traditional | Procter & Gamble Co. | 10/05/2001SE |
| K003843 | Envive MiniformsHHD · Traditional | Procter & Gamble Co. | 02/08/2001SE |
| K993870 | Unscented Interlabial Menstrual PadHHD · Traditional | Procter & Gamble Co. | 01/18/2000SE |
| K980395 | Gladrags Cotton Menstrual PadHHD · Traditional | Keepers!, Inc. | 04/16/1998SE |
| K953470 | Flushies Flushable/Biodegradable Menstrual Pads/Napkins (Ultra Thins)HHD · Traditional | Mediquip, Inc. | 11/21/1995SE |
| K953668 | Unscented Ultrathin Maxi PadHHD · Traditional | Paragon Trade Brands, Inc. | 11/01/1995SE |
| K953667 | Unscented Curved Ultrathin Maxi PadsHHD · Traditional | Paragon Trade Brands, Inc. | 11/01/1995SE |
| K953633 | Unscented Menstrual PadHHD · Traditional | Tendasoft, Inc. | 11/01/1995SE |
| K953553 | Unscented Menstral PadHHD · Traditional | Paragon Trade Brands, Inc. | 10/27/1995SE |
More from Paragon Trade Brands, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K860294 | Hospital Tabbed Napkins Super Belted Feminine NapkHHD · Traditional | 03/13/1986SE |
| K853079 | Protective Pad for IncontinenceEYQ · Traditional | 08/09/1985SE |
| K844975 | Scented Breathable Mini-Shield Private Label BrandHHL · Traditional | 02/25/1985SE |
| K843886 | Scented Breathable Private Label Mini-ShHHL · Traditional | 10/25/1984SE |
| K843602 | Breathable Mini-Shield-Private LabelHHD · Traditional | 10/05/1984SE |
| K820288 | Mini Shields Menstrual PadsHHD · Traditional | 03/05/1982SE |
| K820287 | Maxi Shields Menstrual PadsHHD · Traditional | 03/05/1982SE |
| K813252 | Unscented Menstrual Pads-Mini PadsHHD · Traditional | 12/14/1981SE |
Questions and answers
When was Unscented Menstrual Pads-Maxi Pads cleared by the FDA?
Unscented Menstrual Pads-Maxi Pads (K813251) received a 510(k) decision of Substantially Equivalent on December 14, 1981, 25 days after the submission was received.
What is the product code of K813251?
The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.