NIO
The NIO+ Adult is a single-use, automatic, spring-loaded, intraosseous sterile device with dual safety features for enhanced patient and caregiver safety. The NIO+ is packed in a rigid,…
The NIO+ Adult is a single-use, automatic, spring-loaded, intraosseous sterile device with dual safety features for enhanced patient and caregiver safety. The NIO+ is packed in a rigid, low-profile case and can withstand extreme storage and usage conditions. After deployment, its built-in stabilizer base, in conjunction with a stand-alone NIO+ Fixation dressing, ensures that the needle is firmly secured
Who Else Makes It
Concentrated in Jiangsu (20), Zhejiang (19), Shanghai (12). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Aena Medical (Jiangsu) Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 4 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 71. All 71 manufacturers in China registered for Needle, Hypodermic, Single Lumen
Record
| Listed by | Waismed Ltd., Israel |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K160805 |
| Record published | 2020-08-10 |
| Record revised | 2020-08-11 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 12, carton box of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NIO-P | In distribution | |
| NIO-A | In distribution | |
| NIO Adult+ | In distribution | |
| NIO-I | In distribution | |
| NIO-P | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterile Single-use Syringe with Needle | Jiangxi Hongda Medical Equipment Group Ltd. | 162 |
| Tkmd | Anhui Tiankang Medical Technology Co., Ltd. | 150 |
| Reli | Myco Medical Supplies, Inc. | 149 |
| STERiJECT TM | TSK Laboratory, Japan | 140 |
| Yeso med | Wuxi Yushou Medical Appliances Co., Ltd. | 130 |
| Monoject | Cardinal Health | 124 |
| Monoject | Cardinal Health 200, LLC | 112 |
| Jelco | ICU Medical, Inc | 108 |
| micsafe | Jiangsu Micsafe Medical Tehcnology Co., Ltd. | 105 |
| McKesson | Mckesson Medical-Surgical Inc. | 93 |
| EasyTouch | MHC Medical Products | 82 |
| Medegen Medical products | Medegen Medical Products | 78 |
Showing 12 of 797. All products under Needle, Hypodermic, Single Lumen
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211968 | 2021-07-22 |
| K190538 | 2019-10-07 |
| K160805 | 2016-06-23 |
| K142086 | 2014-08-28 |
| K062940 | 2006-12-22 |
| K022415 | 2002-10-11 |
| K981853 | 1998-11-17 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Waismed Ltd. | 510(k) number | 2025-06-05 | Class II | Process change control | Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion. | 7056 units (US) | |
| Waismed Ltd. | 510(k) number | 2025-06-05 | Class II | Process change control | Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion. | 516 units (US) | |
| Waismed Ltd. | 510(k) number | 2016-08-18 | Class II | Component design/selection | WaisMed received a report in which during the operation of the NIO-A, the needle was not released from the device as expected. The device was placed on the floor and after several minutes the needle was released spontaneously. NIO-A and the | 50 | 2016-12-05 |
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.