FDA product code KIH: Dispenser, Cement
KIH is the FDA product code for dispenser, cement. It is a Class I device, regulated under 21 CFR 888.4200 and reviewed by the Orthopedic panel. FDA has cleared 11 510(k) submissions under KIH, from 7 different applicants. The average 510(k) review took 42 days (median 34). FDA has posted 5 recalls for KIH devices.
Classification
| Field | Value |
|---|---|
| Device name | Dispenser, Cement |
| Device class | Class I |
| Regulation | 21 CFR 888.4200 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KIH clearance
Top KIH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Howmedica Corp. | 3 | 1983-12-12 |
| Johnson & Johnson Professionals, Inc. | 2 | 1994-12-21 |
| Dentsply Intl. | 2 | 1990-03-02 |
| DePuy Orthopaedics, Inc. | 1 | 2004-10-22 |
| Precision Medical Devices, Inc. | 1 | 1984-02-09 |
2 more applicants have KIH clearances. See the full list in Caduvo.
Most recent KIH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K042591 | DePuy Orthopaedics, Inc. | SMARTMIX PRE-FILLED MIXING SYSTEM | 2004-10-22 | 29 |
| K943906 | Johnson & Johnson Professionals, Inc. | P.F.C. CEMENT PRESSURIZING SYSTEM | 1994-12-21 | 132 |
| K897134 | Dentsply Intl. | CMW CEMENT PRESSURISATION SYSTEM | 1990-03-02 | 65 |
| K851881 | Dentsply Intl. | ORTHOPEADIC CEMENT DELIVERY SYSTEM | 1985-06-13 | 45 |
| K840046 | Precision Medical Devices, Inc. | PRESSURIZING/SCAVENGING ACRYLIC CEMENT | 1984-02-09 | 34 |
Recalls for KIH devices
5 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-02-28.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code KIH?
KIH is the FDA product code for dispenser, cement. It is a Class I device, regulated under 21 CFR 888.4200 and reviewed by the Orthopedic panel.
What device class is KIH?
Class I, regulation 21 CFR 888.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KIH?
Across 11 cleared submissions the average was 42 days from receipt to decision (median 34).
Which companies have the most KIH clearances?
Howmedica Corp. (3); Johnson & Johnson Professionals, Inc. (2); Dentsply Intl. (2); DePuy Orthopaedics, Inc. (1); Precision Medical Devices, Inc. (1).
Have KIH devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2019-02-28.
Next steps
- Run an FDA pathway report with predicate devices for product code KIH
- Run a recall and safety report across every KIH manufacturer
- Watch product code KIH 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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