Welch Allyn, Inc.
KleenSpec Illumination System (with cord)—4.7 V Halogen Light Handle with on/off switch and transformer, 110-130 V, 60 Hz for North America
40manufacturers in China registered for this device type
30catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (15), Zhejiang (15), Shanghai (5). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Linhai Deyi Plastic Co., Ltd. | Linhai | Zhejiang | Contract manufacturer | 15 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
Showing 12 of 40. All 40 manufacturers in China registered for Speculum, Vaginal, Nonmetal
Record
| Listed by | Welch Allyn, Inc., United States |
|---|---|
| FDA product code | HIB |
| Device type | Speculum, Vaginal, Nonmetal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K120743 |
| Record published | 2021-04-30 |
| Record revised | 2023-09-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Pack of 4, pack of 24, pack of 18, pack of 12, pack of 5 |
| Distribution end date | 2025-06-19 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 901070 | In distribution | ||
| 901071 | In distribution | ||
| 901070 | In distribution | ||
| 901071 | In distribution | ||
| 901071 | In distribution | ||
| 901017 | 100 | In distribution | |
| 901070 | In distribution | ||
| 901071 | In distribution | ||
| 901071 | In distribution | ||
| 901071 | In distribution | ||
| 901071 | In distribution | ||
| 901071 | In distribution | ||
| 901070 | In distribution | ||
| 901071 | In distribution | ||
| 901070 | In distribution | ||
| 901071 | In distribution | ||
| 901017 | 25 | In distribution | |
| 901071 | In distribution | ||
| 901070 | In distribution | ||
| 901070 | In distribution | ||
| 901071 | In distribution | ||
| 901070 | In distribution | ||
| 901071 | In distribution | ||
| 901070 | In distribution | ||
| 901071 | In distribution | ||
| 901070 | Withdrawn | ||
| 901071 | Withdrawn | ||
| 901071 | Withdrawn | ||
| 901071 | Withdrawn | ||
| 901071 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vagispec Kolplast | Kolplast C I | 19 |
| EOS | North EOS Industries, Inc. | 19 |
| Shengbo | Yuhuan City Shengbo Mould Manufacturing Co., Ltd. | 18 |
| Centurion | Centurion Medical Products Corporation | 13 |
| ClearSpec | Clearspec, LLC | 12 |
| Speculux | Evexar Medical Limited | 12 |
| McKesson. | Mckesson Medical-Surgical Inc. | 11 |
| Instraspec | Robinson Healthcare Limited | 10 |
| PremierPro | Prestige Ameritech | 9 |
| Bioseal Inc. | Bioseal | 9 |
| ER-Spec/Office-Spec | OBP Medical Corporation | 6 |
| Medline | Medline Industries, Inc. | 6 |
Showing 12 of 75. All products under Speculum, Vaginal, Nonmetal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120743 | 2012-03-23 |
| K070964 | 2007-05-18 |
| K941272 | 1994-08-02 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Welch Allyn, Inc. | 510(k) number | 2015-10-02 | Class II | Device Design | The firm became aware that the KleenSpec 788 Corded Illuminator has the potential to be incorrectly connected to a commonly available AC power cord instead of the illuminator low voltage transformer power cord which is supplied with the ill | Domestic: 179,401 units, Foreign: 15,063 units | 2018-05-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.