FDA product code NTX: Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
NTX is the FDA product code for nursing pad, polyurethane pad with starch copolymer, glycerin, and surfactant (f-68). It is a Class I device, regulated under 21 CFR 880.5630 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under NTX. The average 510(k) review took 636 days (median 636).
Definition
A NURSING PAD CONSISTING OF A POLYURETHANE PAD WITH GLYCERIN USED TO RELIEVE NIPPLES THAT ARE SORE AND CRACKED FROM BREASTFEEDING.
Classification
| Field | Value |
|---|---|
| Device name | Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) |
| Device class | Class I |
| Regulation | 21 CFR 880.5630 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NTX clearance
Top NTX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ferris Mfg. Corp. | 1 | 2005-02-22 |
Most recent NTX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K031660 | Ferris Mfg. Corp. | FERRIS POLYMEM STERILE BREAST PAD | 2005-02-22 | 636 |
Recalls for NTX devices
openFDA lists no recalls for product code NTX.
Frequently asked questions
What is FDA product code NTX?
NTX is the FDA product code for nursing pad, polyurethane pad with starch copolymer, glycerin, and surfactant (f-68). It is a Class I device, regulated under 21 CFR 880.5630 and reviewed by the General Hospital panel.
What device class is NTX?
Class I, regulation 21 CFR 880.5630. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NTX?
Across 1 cleared submissions the average was 636 days from receipt to decision (median 636).
Which companies have the most NTX clearances?
Ferris Mfg. Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NTX
- Run a recall and safety report across every NTX manufacturer
- Watch product code NTX 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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