510(k) · Cleared
ClearedCritical Care Assessment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Critical Patient Care, Inc. · JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Cleared on Sep 21, 2010 as substantially equivalent to K083735 (Medtechs, LLC, 2009) after a 69-day review. Its family tree reaches back 4 generations to 1985. 1 later device descends from it.
- Decided
- Sep 21, 2010
- Review
- 69 days
- Class
- Class II
- Product code
- JOM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K853124 (1985). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK853124 Novametrix Pulse Oximeter, Model 500Novametrix Medical Systems, Inc. · 1985
- 3 generations backK023238 McpulseMeridian Co., Ltd. · 2003
- 2 generations backK073323 SA-3000PMedicore Co., Ltd. · 2007
- 1 generation backK083735 Ansha Autonomic Nervous System Health Assessment PlusMedtechs, LLC · 2009
- This deviceK101983 Critical Care AssessmentCritical Patient Care, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK191266 VitalScan ANSMedeia, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K191266VitalScan ANSMedeia, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K853124 | Novametrix Pulse Oximeter, Model 500 | Novametrix Medical Systems, Inc. | 1985 | — |
| −3 | K023238 | Mcpulse | Meridian Co., Ltd. | 2003 | — |
| −2 | K073323 | SA-3000P | Medicore Co., Ltd. | 2007 | — |
| −1 | K083735 | Ansha Autonomic Nervous System Health Assessment Plus | Medtechs, LLC | 2009 | — |
| 0 (this device) | K101983 | Critical Care Assessment | Critical Patient Care, Inc. | 2010 | — |
| +1 | K191266 | VitalScan ANS | Medeia, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JOM? 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 JOM device
- #1 K220527 PADnet Xpressscore 5.1 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083735 | Ansha Autonomic Nervous System Health Assessment PlusSummary page 1…tic or hydraulic Regulation Number: 21 CFR 870.2780 3. Substantial Equivalence: ANSHA -QHRV1 K083735 Reason for submission: Re-labeling device under new trade name. Performance: Th… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191266 | VitalScan ANS | 2020 | 0 |
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?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K191266 (Medeia, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K083735.
How does its category compare?
All JOM devicesJOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · JOM
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · JOM
Too few JOM 510(k)s in any year since 2007 to give a median.
Recalls per year · JOM
No recall names JOM since 2007.
Adverse event reports per year · JOM
1in 2007
MAUDE reports naming product code JOM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
'Critical Care Assessment' is intended for noninvasive measurements of pulse waveforms by photoelectric plethysmography and heart rate electrocardiograph. The system is intended for use of patients in medical clinics, healthcare practices and in out-patient department of hospitals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101983 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101983: Critical Care Assessment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101983
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026