510(k) Report

510(k) · Cleared

Cleared

Rubicon Prothrombin Time Monitoring System

K001699510(k) TraditionalCleared May 15, 2001347-day reviewClass II21 CFR 864.7750

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

Lifescan, Inc. · GJS Test, Time, Prothrombin

Cleared on May 15, 2001 after a 347-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
May 15, 2001
Review
347 days
Class
Class II
Product code
GJS
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared200020052010201520202025
  1. This deviceK001699 Rubicon Prothrombin Time Monitoring SystemLifescan, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK022922 Harmony Inr Monitoring SystemLifescan, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K022922Harmony Inr Monitoring SystemLifescan, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001699Rubicon Prothrombin Time Monitoring SystemLifescan, Inc.2001—
+1K022922Harmony Inr Monitoring SystemLifescan, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K001699, 2001–2002Source: 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 GJS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GJS device

  1. #1 K243543 microINR Systemscore 13.4 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K022922Harmony Inr Monitoring SystemLifescan, Inc.20020

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, K022922 (Lifescan, Inc., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GJS devices

GJS Test, Time, Prothrombin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GJS

3in 2025

2007: 42008: 12010: 42012: 12013: 12014: 12016: 12017: 12018: 22019: 22020: 12022: 32023: 22024: 12025: 3
2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GJS

60in 2025

2007: 77 days median2010: 168 days median2022: 399 days median2025: 60 days median
2007high 399 (2022) · low 60 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GJS

1in 2022

2007: 52008: 32009: 42010: 22011: 12012: 12013: 12014: 4, 3 Class I2017: 52018: 3, 2 Class I2020: 22021: 12022: 1
2007high 5 (2007) · low 0 (2015)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · GJS

105in 2025

2007: 4392008: 4202009: 8762010: 2,1772011: 2,9652012: 2,1982013: 2,5842014: 2,3972015: 1,2602016: 8642017: 5322018: 1,9582019: 2,3852020: 1,3902021: 1,3592022: 1,2102023: 8092024: 1772025: 105
2007high 2,965 (2011) · low 105 (2025)2025

MAUDE reports naming product code GJS, 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
20074775439
20081—3420
20090—4876
2010416822,177
20110—12,965
20121—12,198
20131—12,584
20141—4 (3)2,397
20150—01,260
20161—0864
20171—5532
20182—3 (2)1,958
20192—02,385
20201—21,390
20210—11,359
2022339911,210
20232—0809
20241—0177
20253600105
20260—0—

More from Lifescan, Inc.

42 FDA decisions under this applicant name. See the company

  • K132618Onetouch RevealLifescan, Inc. · 2013
  • K120558Onetouch Reveal Diabetes Management ApplicationLifescan, Inc. · 2013
  • K093745One Touch Verio Blood Glucose Monitoring SystemLifescan, Inc. · 2011
  • K082590Symphony Meter RemoteLifescan, Inc. · 2008
  • K082513Onetouch Vita Blood Glucose Monitoring SystemLifescan, Inc. · 2008

Recent decisions in GJS

The GJS category page

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  • K243543microINR SystemIline Microsystems, S.L. · 2025
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https://510kreport.com/device/K001699 · printed Nov 5, 2026

Cite this page

510(k) Report. “K001699: Rubicon Prothrombin Time Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001699

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