510(k) Report

510(k) · Cleared

Cleared

Pulse Oximeter Model 305

K943842510(k) TraditionalCleared Mar 24, 1995231-day reviewClass II21 CFR 870.2700

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

Palco Laboratories, Inc. · DQA Oximeter

Cleared on Mar 24, 1995 after a 231-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Mar 24, 1995
Review
231 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
0

6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2007: 1 descendant cleared2011: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared1995200020052010201520202025
  1. This deviceK943842 Pulse Oximeter Model 305Palco Laboratories, Inc. · 1995
  2. Descendant · cites it directly · 4 of its ownK071610 Mediaid Pulse Oximeter M30 and M34Mediaid, Inc. · 2007
  3. Descendant · 2 generations on · 3 of its ownK100225 Pulse Oximeter Model P10Mediana Co., Ltd. · 2011
  4. Descendant · 3 generations on · 2 of its ownK152659 V10Mediana Co., Ltd. · 2016
  5. Descendant · 4 generations on · 1 of its ownK170497 V10Mediana Co., Ltd. · 2017 · Recalled
  6. Descendant · 5 generations on · 0 of its ownK200434 V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12011: 12016: 12017: 12020: 1
2007high 1 (2007) · low 0 (2009)2026

Most influential descendants

Showing 5 of 6 · See all
  • K071610Mediaid Pulse Oximeter M30 and M34Mediaid, Inc. · 2007 · cites it directly4descendants
  • K100225Pulse Oximeter Model P10Mediana Co., Ltd. · 2011 · 2 generations on3descendants
  • K152659V10Mediana Co., Ltd. · 2016 · 3 generations on2descendants
  • K170497V10Mediana Co., Ltd. · 2017 · 4 generations on1descendant
  • K200434V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943842Pulse Oximeter Model 305Palco Laboratories, Inc.1995—
+1K071610Mediaid Pulse Oximeter M30 and M34Mediaid, Inc.2007—
+2K100225Pulse Oximeter Model P10Mediana Co., Ltd.2011—
+3K152659V10Mediana Co., Ltd.2016—
+4K170497V10Mediana Co., Ltd.20171
+5K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.20201

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201110
201610
201710
202010
FIG. 1 — Lineage of K943842, 1995–2020Source: 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 DQA? 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 DQA device

  1. #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K071610Mediaid Pulse Oximeter M30 and M34Mediaid, Inc.20074
K071642Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse OximeterMediaid, Inc.20080

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, K071610 (Mediaid, Inc., 2007) has gone furthest, with 4 descendants of its own.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007: 202008: 222009: 352010: 292011: 152012: 142013: 152014: 112015: 132016: 142017: 92018: 182019: 192020: 152021: 102022: 202023: 132024: 142025: 152026 (partial year): 8
2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007: 122 days median2008: 97 days median2009: 117 days median2010: 127 days median2011: 195 days median2012: 120 days median2013: 182 days median2014: 175 days median2015: 158 days median2016: 246 days median2017: 200 days median2018: 260 days median2019: 158 days median2020: 126 days median2021: 174 days median2022: 265 days median2023: 317 days median2024: 285 days median2025: 182 days median2026 (partial year): 187 days median
2007high 317 (2023) · low 97 (2008)2026

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

Recalls per year · DQA

3in 2024

2007: 62008: 52009: 292010: 42011: 12014: 22015: 12018: 322024: 3
2007high 32 (2018) · low 0 (2012)2026

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

Adverse event reports per year · DQA

399in 2025

2007: 3252008: 3122009: 2812010: 1852011: 1642012: 3222013: 4682014: 1,1242015: 2,0822016: 1,7752017: 1,1902018: 6942019: 5482020: 4262021: 5532022: 4782023: 3922024: 5452025: 399
2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, 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
2007201226325
200822975312
20093511729281
2010291274185
2011151951164
2012141200322
2013151820468
20141117521,124
20151315812,082
20161424601,775
2017920001,190
20181826032694
2019191580548
2020151260426
2021101740553
2022202650478
2023133170392
2024142853545
2025151820399
202681870—

More from Palco Laboratories, Inc.

9 FDA decisions under this applicant name. See the company

  • K942810Palco Labs Cold PouchPalco Laboratories, Inc. · 1995
  • K920066Palco Labs Model 340 Pulse OximeterPalco Laboratories, Inc. · 1993
  • K913694Palco Labs LoadmaticPalco Laboratories, Inc. · 1991
  • K911191Palco Labs Model 300 Oxygen/Pulse MonitorPalco Laboratories, Inc. · 1991
  • K904988Palco Labs Model 400 Oxygen/Pulse MonitorPalco Laboratories, Inc. · 1991

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https://510kreport.com/device/K943842 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943842: Pulse Oximeter Model 305.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943842

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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