FDA product code IPY: Orthosis, Lumbo-Sacral
IPY is the FDA product code for orthosis, lumbo-sacral. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel. FDA has cleared 11 510(k) submissions under IPY, from 8 different applicants. The average 510(k) review took 24 days (median 20). FDA has posted 1 recall for IPY devices.
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Lumbo-Sacral |
| Device class | Class I |
| Regulation | 21 CFR 890.3490 |
| 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 IPY clearance
Top IPY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthomedics | 3 | 1981-03-13 |
| Surgical Appliance Industries, Inc. | 2 | 1981-09-14 |
| Buckman Consultants | 1 | 1983-01-17 |
| Danek Medical, Inc. | 1 | 1983-01-14 |
| David Hendricks, C.P.O. | 1 | 1981-08-13 |
3 more applicants have IPY clearances. See the full list in Caduvo.
Most recent IPY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823882 | Buckman Consultants | M-BRACE | 1983-01-17 | 21 |
| K823823 | Danek Medical, Inc. | LUMBOSACRAL SUPPORT | 1983-01-14 | 28 |
| K812422 | Surgical Appliance Industries, Inc. | CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS | 1981-09-14 | 21 |
| K812099 | David Hendricks, C.P.O. | CASH ORTHOSIS | 1981-08-13 | 20 |
| K811494 | Surgical Appliance Industries, Inc. | LUMBO-SACRAL FLEXION ORTHOSIS | 1981-06-16 | 20 |
Recalls for IPY devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-02-24.
Frequently asked questions
What is FDA product code IPY?
IPY is the FDA product code for orthosis, lumbo-sacral. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel.
What device class is IPY?
Class I, regulation 21 CFR 890.3490. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IPY?
Across 11 cleared submissions the average was 24 days from receipt to decision (median 20).
Which companies have the most IPY clearances?
Orthomedics (3); Surgical Appliance Industries, Inc. (2); Buckman Consultants (1); Danek Medical, Inc. (1); David Hendricks, C.P.O. (1).
Have IPY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-02-24.
Next steps
- Run an FDA pathway report with predicate devices for product code IPY
- Run a recall and safety report across every IPY manufacturer
- Watch product code IPY 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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