510(k) Report

510(k) · Cleared

Cleared

Peripheral Arterial Tonometer-Pat 1000RD Device

K001852510(k) TraditionalCleared Feb 21, 2001247-day reviewClass II21 CFR 870.1425

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

Itamar Medical (C.M.) 1997, Ltd. · DQK Computer, Diagnostic, Programmable

Cleared on Feb 21, 2001 after a 247-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Feb 21, 2001
Review
247 days
Class
Class II
Product code
DQK
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared2022: 1 descendant cleared2007: 1 descendant cleared200020052010201520202025
  1. This deviceK001852 Peripheral Arterial Tonometer-Pat 1000RD DeviceItamar Medical (C.M.) 1997, Ltd. · 2001
  2. Descendant · cites it directly · 2 of its ownK032519 Endo Pat 2000Itamar Medical · 2003
  3. Descendant · 2 generations on · 0 of its ownK211557 EndoPATxItamar Medical, Ltd. · 2022
  4. Descendant · 2 generations on · 0 of its ownK060980 Vendys Model 5000 B/BCEndothelix, Inc. · 2007

Most influential descendants

Showing 3 of 3 · See all
  • K032519Endo Pat 2000Itamar Medical · 2003 · cites it directly2descendants
  • K211557EndoPATxItamar Medical, Ltd. · 2022 · 2 generations on0descendants
  • K060980Vendys Model 5000 B/BCEndothelix, Inc. · 2007 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001852Peripheral Arterial Tonometer-Pat 1000RD DeviceItamar Medical (C.M.) 1997, Ltd.2001—
+1K032519Endo Pat 2000Itamar Medical2003—
+2K211557EndoPATxItamar Medical, Ltd.2022—
+2K060980Vendys Model 5000 B/BCEndothelix, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200710
202210
FIG. 1 — Lineage of K001852, 2001–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 DQK? 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 DQK device

  1. #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K032519Endo Pat 2000Itamar Medical20032

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, K032519 (Itamar Medical, 2003) has gone furthest, with 2 descendants of its own.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQK

23so far in 2026, the most since 2007

2007: 132008: 42009: 122010: 92011: 122012: 72013: 132014: 92015: 72016: 152017: 72018: 142019: 152020: 162021: 162022: 192023: 212024: 132025: 222026 (partial year): 23
2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007: 83 days median2008: 70 days median2009: 93 days median2010: 64 days median2011: 69 days median2012: 74 days median2013: 68 days median2014: 90 days median2015: 125 days median2016: 190 days median2017: 146 days median2018: 150 days median2019: 113 days median2020: 123 days median2021: 132 days median2022: 136 days median2023: 133 days median2024: 100 days median2025: 95 days median2026 (partial year): 151 days median
2007high 190 (2016) · low 64 (2010)2026

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

Recalls per year · DQK

1in 2025

2007: 42008: 12009: 22010: 32011: 22012: 32013: 12014: 42015: 22017: 22018: 62019: 12020: 12021: 12022: 22023: 22024: 242025: 12026 (partial year): 2
2007high 24 (2024) · low 0 (2016)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQK

433in 2025

2007: 182008: 342009: 402010: 492011: 552012: 1292013: 1802014: 1152015: 1312016: 3402017: 2522018: 2612019: 2182020: 2152021: 3512022: 3192023: 3402024: 5572025: 433
2007high 557 (2024) · low 18 (2007)2025

MAUDE reports naming product code DQK, 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
20071383418
2008470134
20091293240
2010964349
20111269255
20127743129
201313681180
20149904115
201571252131
2016151900340
201771462252
2018141506261
2019151131218
2020161231215
2021161321351
2022191362319
2023211332340
20241310024557
202522951433
2026231512—

More from Itamar Medical (C.M.) 1997, Ltd.

3 FDA decisions under this applicant name. See the company

  • K010156Sleep Pat 200 DeviceItamar Medical (C.M.) 1997, Ltd. · 2002
  • K010739Watch-Pat 100Itamar Medical (C.M.) 1997, Ltd. · 2001

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https://510kreport.com/device/K001852 · printed Nov 5, 2026

Cite this page

510(k) Report. “K001852: Peripheral Arterial Tonometer-Pat 1000RD Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001852

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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