FDA product code KTC: Bath, Sitz, Nonpowered
KTC is the FDA product code for bath, sitz, nonpowered. It is a Class I device, regulated under 21 CFR 890.5125 and reviewed by the Physical Medicine panel. FDA has cleared 7 510(k) submissions under KTC, from 7 different applicants. The average 510(k) review took 40 days (median 23).
Classification
| Field | Value |
|---|---|
| Device name | Bath, Sitz, Nonpowered |
| Device class | Class I |
| Regulation | 21 CFR 890.5125 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KTC clearance
Top KTC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Spritz Co. | 1 | 1991-08-28 |
| Drummond Industries, Inc. | 1 | 1989-02-13 |
| W. C. Green, D.D.S. | 1 | 1986-07-18 |
| Abco Dealers, Inc. | 1 | 1985-07-01 |
| Mac Lee Medical Products | 1 | 1984-05-07 |
2 more applicants have KTC clearances. See the full list in Caduvo.
Most recent KTC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K912179 | The Spritz Co. | THE SPRITZ BATH | 1991-08-28 | 104 |
| K890085 | Drummond Industries, Inc. | SIT-N-BATHE SITZ BATH | 1989-02-13 | 34 |
| K862600 | W. C. Green, D.D.S. | SITZ BATH | 1986-07-18 | 10 |
| K851309 | Abco Dealers, Inc. | ABCO PLASTIC UTENSILS | 1985-07-01 | 90 |
| K841711 | Mac Lee Medical Products | MAC LEE SITZ BATH | 1984-05-07 | 13 |
Recalls for KTC devices
openFDA lists no recalls for product code KTC.
Frequently asked questions
What is FDA product code KTC?
KTC is the FDA product code for bath, sitz, nonpowered. It is a Class I device, regulated under 21 CFR 890.5125 and reviewed by the Physical Medicine panel.
What device class is KTC?
Class I, regulation 21 CFR 890.5125. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KTC?
Across 7 cleared submissions the average was 40 days from receipt to decision (median 23).
Which companies have the most KTC clearances?
The Spritz Co. (1); Drummond Industries, Inc. (1); W. C. Green, D.D.S. (1); Abco Dealers, Inc. (1); Mac Lee Medical Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KTC
- Run a recall and safety report across every KTC manufacturer
- Watch product code KTC 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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