FDA product code KIJ: Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
KIJ is the FDA product code for instrument, surgical, orthopedic, dc-powered motor and accessory/attachment. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the Orthopedic panel. FDA has cleared 29 510(k) submissions under KIJ, from 21 different applicants. The average 510(k) review took 138 days (median 87). FDA has posted 10 recalls for KIJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| Review panel | OR — Orthopedic |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KIJ clearance
Top KIJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Black & Decker(Tm) | 5 | 1980-03-19 |
| Dyonics, Inc. | 3 | 1988-12-07 |
| Jeil Medical Corporation | 2 | 2016-12-27 |
| Aeg Power Tool Corp. | 2 | 1985-03-11 |
| Insurgical, LLC | 1 | 2012-11-06 |
16 more applicants have KIJ clearances. See the full list in Caduvo.
Most recent KIJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K163308 | Jeil Medical Corporation | SMARTO | 2016-12-27 | 34 |
| K112599 | Insurgical, LLC | INSURGICAL SINGLE USE POWER EQUIPMENT | 2012-11-06 | 426 |
| K101563 | Jeil Medical Corporation | SMARTO | 2010-12-17 | 196 |
| K972367 | Stryker Instruments | STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT | 1997-09-04 | 71 |
| K970378 | Implant Resource, Inc. | STRYKER 2115 REPLACEMENT BATTERY (2115) | 1997-04-30 | 89 |
Recalls for KIJ devices
10 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-10-10.
Frequently asked questions
What is FDA product code KIJ?
KIJ is the FDA product code for instrument, surgical, orthopedic, dc-powered motor and accessory/attachment. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the Orthopedic panel.
What device class is KIJ?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KIJ?
Across 29 cleared submissions the average was 138 days from receipt to decision (median 87).
Which companies have the most KIJ clearances?
Black & Decker(Tm) (5); Dyonics, Inc. (3); Jeil Medical Corporation (2); Aeg Power Tool Corp. (2); Insurgical, LLC (1).
Have KIJ devices been recalled?
Yes: 10 product recalls across 1 recall events; the most recent began 2008-10-10.
Next steps
- Run an FDA pathway report with predicate devices for product code KIJ
- Run a recall and safety report across every KIJ manufacturer
- Watch product code KIJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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