510(k) · Cleared
ClearedTSX PRM Pulmonary Resuscitation Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spiracle Technology · CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Cleared on Jul 23, 1998 as substantially equivalent to K812140 (3M Company, 1981) after a 321-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Jul 23, 1998
- Review
- 321 days
- Class
- Class II
- Product code
- CAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K812140 (1981). No later device cites it as a predicate yet.
- Root · 1 generation backK812140 Bird Mean Airway Pressure Monitor3M Company · 1981
- This deviceK973347 TSX PRM Pulmonary Resuscitation MonitorSpiracle Technology · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K812140 | Bird Mean Airway Pressure Monitor | 3M Company | 1981 | — |
| 0 (this device) | K973347 | TSX PRM Pulmonary Resuscitation Monitor | Spiracle Technology | 1998 | — |
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 CAP? 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 CAP device
- #1 K201666 Single Use Manometerscore 0.3 · 1 generation · no Class I recall
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K812140 | Bird Mean Airway Pressure MonitorSummary page 1…ion Monitor Common Names: Respiratory Monitor Classification Name: Airway Pressure Monitor 21 C.F.R. 868.2600 Predicate Devices (1) Bird Mean Airway Pressure Monitor (K812140) (2) Sechrist Industries, Inc., Airway Pressure Monitor Model 400 (K814608) Intended Use The TDx PRM is intended to be used as… | 1981 |
| Kept off the family tree | K814608 | Sechrist Industries, Inc., Airway Pressure Monitor Model 400 Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…ressure Monitor 21 C.F.R. 868.2600 Predicate Devices (1) Bird Mean Airway Pressure Monitor (K812140) (2) Sechrist Industries, Inc., Airway Pressure Monitor Model 400 (K814608) Intended Use The TDx PRM is intended to be used as an accessory to emergency resuscitators to monitor v-ntilatory functions in… |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All CAP devicesCAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAP
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · CAP
Too few CAP 510(k)s in any year since 2007 to give a median.
Recalls per year · CAP
No recall names CAP since 2007.
Adverse event reports per year · CAP
2in 2025
MAUDE reports naming product code CAP, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TDx PRM is intended to be used as an accessory to emergency resuscitators and ventilators to monitor ventilatory functions including peak inspiratory pressure, respiratory rate, positive end expiratory pressure, and inspiratory/expiratory time ratio.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973347: TSX PRM Pulmonary Resuscitation Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973347
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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