FDA product code LNW: Paper, Obstetric Ph
LNW is the FDA product code for paper, obstetric ph. It is a Class I device, regulated under 21 CFR 862.1550 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 4 510(k) submissions under LNW, from 3 different applicants. The average 510(k) review took 84 days (median 84). FDA has posted 2 recalls for LNW devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Paper, Obstetric Ph |
| Device class | Class I |
| Regulation | 21 CFR 862.1550 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LNW clearance
Top LNW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Femtek,Llc. | 2 | 2003-09-30 |
| Femtek, Inc. | 1 | 1996-05-13 |
| Uro Pharmaceuticals, Inc. | 1 | 1985-05-24 |
Most recent LNW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K032161 | Femtek,Llc. | PHEM-ALERT | 2003-09-30 | 77 |
| K012230 | Femtek,Llc. | PHEM-ALERT | 2001-10-09 | 85 |
| K960648 | Femtek, Inc. | PHEM-CHEK | 1996-05-13 | 89 |
| K850858 | Uro Pharmaceuticals, Inc. | OB-PH - PH TEST PAPER | 1985-05-24 | 84 |
Recalls for LNW devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-22.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code LNW?
LNW is the FDA product code for paper, obstetric ph. It is a Class I device, regulated under 21 CFR 862.1550 and reviewed by the Obstetrics and Gynecology panel.
What device class is LNW?
Class I, regulation 21 CFR 862.1550. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LNW?
Across 4 cleared submissions the average was 84 days from receipt to decision (median 84).
Which companies have the most LNW clearances?
Femtek,Llc. (2); Femtek, Inc. (1); Uro Pharmaceuticals, Inc. (1).
Have LNW devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-11-22.
Next steps
- Run an FDA pathway report with predicate devices for product code LNW
- Run a recall and safety report across every LNW manufacturer
- Watch product code LNW 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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