FDA product code PDH: Blanket, Neonatal Phototherapy
PDH is the FDA product code for blanket, neonatal phototherapy. It is a Class II device, regulated under 21 CFR 880.5700 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under PDH, from 2 different applicants. The average 510(k) review took 205 days (median 205). FDA has posted 1 recall for PDH devices.
Definition
Is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting.
Classification
| Field | Value |
|---|---|
| Device name | Blanket, Neonatal Phototherapy |
| Device class | Class II |
| Regulation | 21 CFR 880.5700 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every PDH clearance
Top PDH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Salter Labs | 1 | 2015-06-12 |
| Bionix Development Corp. | 1 | 2013-03-07 |
Most recent PDH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K142416 | Salter Labs | Luma Wrap | 2015-06-12 | 288 |
| K123411 | Bionix Development Corp. | LITTLE ANGELS SWADDLING BLANKET | 2013-03-07 | 122 |
Recalls for PDH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-07-11.
Frequently asked questions
What is FDA product code PDH?
PDH is the FDA product code for blanket, neonatal phototherapy. It is a Class II device, regulated under 21 CFR 880.5700 and reviewed by the General Hospital panel.
What device class is PDH?
Class II, regulation 21 CFR 880.5700. Typical premarket route: 510(k).
How long does a 510(k) take for product code PDH?
Across 2 cleared submissions the average was 205 days from receipt to decision (median 205).
Which companies have the most PDH clearances?
Salter Labs (1); Bionix Development Corp. (1).
Have PDH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-07-11.
Next steps
- Run an FDA pathway report with predicate devices for product code PDH
- Run a recall and safety report across every PDH manufacturer
- Watch product code PDH 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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