510(k) Report

510(k) · Cleared

Cleared

OB-PH - PH Test Paper

K850858510(k) TraditionalCleared May 24, 198584-day reviewClass I21 CFR 862.1550

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Uro Pharmaceuticals, Inc. · LNW Paper, Obstetric Ph

Cleared on May 24, 1985 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
May 24, 1985
Review
84 days
Class
Class I
Product code
LNW
Recalls
None
Predicates
0

4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared2009: 1 descendant cleared2001: 1 descendant cleared2003: 1 descendant cleared1990200020102020
  1. This deviceK850858 OB-PH - PH Test PaperUro Pharmaceuticals, Inc. · 1985
  2. Descendant · cites it directly · 3 of its ownK960648 Phem-ChekFemtek, Inc. · 1996
  3. Descendant · 2 generations on · 1 of its ownK012230 Phem-AlertFemtek,Llc. · 2001
  4. Descendant · 2 generations on · 0 of its ownK091287 VS-Sense TestCommon Sense, Ltd. · 2009
  5. Descendant · 3 generations on · 0 of its ownK032161 Phem-AlertFemtek,Llc. · 2003

Most influential descendants

Showing 4 of 4 · See all
  • K960648Phem-ChekFemtek, Inc. · 1996 · cites it directly3descendants
  • K012230Phem-AlertFemtek,Llc. · 2001 · 2 generations on1descendant
  • K091287VS-Sense TestCommon Sense, Ltd. · 2009 · 2 generations on0descendants
  • K032161Phem-AlertFemtek,Llc. · 2003 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K850858OB-PH - PH Test PaperUro Pharmaceuticals, Inc.1985—
+1K960648Phem-ChekFemtek, Inc.1996—
+2K012230Phem-AlertFemtek,Llc.2001—
+2K091287VS-Sense TestCommon Sense, Ltd.2009—
+3K032161Phem-AlertFemtek,Llc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200110
200310
200910
FIG. 1 — Lineage of K850858, 1985–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LNW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K960648Phem-ChekFemtek, Inc.19963

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K960648 (Femtek, Inc., 1996) has gone furthest, with 3 descendants of its own.

How does its category compare?

All LNW devices

LNW Paper, Obstetric Ph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNW

FDA has decided no LNW device since 2007.

Median 510(k) review, days · LNW

Too few LNW 510(k)s in any year since 2007 to give a median.

Recalls per year · LNW

No recall names LNW since 2007.

Adverse event reports per year · LNW

1in 2022

2010: 12022: 1
2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code LNW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—01
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

Recent decisions in LNW

The LNW category page

  • K032161Phem-AlertFemtek,Llc. · 2003
  • K012230Phem-AlertFemtek,Llc. · 2001
  • K960648Phem-ChekFemtek, Inc. · 1996

https://510kreport.com/device/K850858 · printed Nov 6, 2026

Cite this page

510(k) Report. “K850858: OB-PH - PH Test Paper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K850858

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026