Speculum, Vaginal, Nonmetal
FDA 510(k) K120743 · Welch Allyn, Inc.
510(k) numberK120743
Submission
- Device name
- Speculum, Vaginal, Nonmetal
- Applicant
- Welch Allyn, Inc.
Skaneateles Falls, NY, US - Received
- March 12, 2012
- Decision date
- March 23, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HIB – Speculum, Vaginal, Nonmetal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252208 | JFord Speculum SleeveHIB · Traditional | Ford Medtech, LLC | 03/06/2026SE |
| K133857 | Brella-Spec(Tm) Vaginal SpeculumHIB · Traditional | Proa Medical, Inc. | 04/28/2014SE |
| K132668 | Iob Disposable SpeculumHIB · Traditional | Iob Medical, Inc. | 01/17/2014SE |
| K130046 | Clearspec Single Use Vaginal SpeculumHIB · Traditional | Clearspec, LLC | 08/06/2013SE |
| K110766 | Kolplux SystemHIB · Traditional | Kolplast CI Ltda | 09/15/2011SE |
| K092870 | Non-Sterile Disposable Vaginal SpeculumHIB · Traditional | Kunshan Deyi Plastic Co., Ltd. | 02/16/2010SE |
| K091937 | Office-Spec Disposable Side-Opening SpeculumHIB · Traditional | Obp Corporation | 09/09/2009SE |
| K072942 | Medline Disposable Vaginal SpeculumHIB · Traditional | Medline Industries, Inc. | 02/08/2008SE |
| K072762 | Depalt Vaginal Specuim and Depalt Lighting SystemHIB · Traditional | Depalt, Inc. | 01/22/2008SE |
| K070964 | Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination SystemHIB · Special | Welch Allyn, Inc. | 05/18/2007SE |
More from Welch Allyn, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243598 | Welch Allyn Connex® 360 (Multiple) · Traditional | 07/13/2025SE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional | 12/20/2024SE |
| K223381 | iExaminer System with Panoptic PlusHKI · Traditional | 03/15/2023SE |
| K212473 | Welch Allyn Connex Central StationMWI · Traditional | 10/28/2022SE |
| K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionBZG · Traditional | 09/10/2019SE |
| K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image SystemNFJ · Traditional | 07/16/2018SE |
| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…MHX · Special | 06/30/2017SE |
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor CoreMWI · Traditional | 12/19/2014SE |
| K141582 | CP150 Electrocardiograph with Spirometry OptionDPS · Special | 07/11/2014SE |
| K132807 | Monitoring Station, Connex(R) Central Station (CS)MWI · Special | 01/31/2014SE |
Questions and answers
When was Speculum, Vaginal, Nonmetal cleared by the FDA?
Speculum, Vaginal, Nonmetal (K120743) received a 510(k) decision of Substantially Equivalent on March 23, 2012, 11 days after the submission was received.
What is the product code of K120743?
The FDA product code is HIB – Speculum, Vaginal, Nonmetal, a Class II (moderate risk) device regulated under 21 CFR 884.4530.