510(k) · Cleared
ClearedGio Digital Pressure Guages
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galemed Corp. · CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Cleared on Aug 22, 2013 as substantially equivalent to K904935 (Respironics, Inc., 1991) and 2 other predicates after a 359-day review. Its family tree reaches back 7 generations to 1986.
- Decided
- Aug 22, 2013
- Review
- 359 days
- Class
- Class II
- Product code
- CAP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K862830 (1986). 26 ancestors in all, the oldest K801883 (1980). No later device cites it as a predicate yet.
- Root · 7 generations backK862830 Models 2R and 3R Pneupac Ventilator/ResuscitatorPneupac, Ltd. · 1986
- 6 generations backK024344 Pneuton VentilatorAiron Corporation · 2003
- 5 generations backK043085 Modification to: Pneuton VentilatorAiron Corporation · 2004
- 4 generations backK080692 Macs Cpap SystemAiron Corporation · 2008
- 3 generations backK092085 Ispira Resuscitation UnitNeoforce Group, Inc. · 2009
- 2 generations backK102649 Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc. · 2011
- 1 generation backK110119 Pressure ManometerNeoforce Group, Inc. · 2011
- This deviceK122627 Gio Digital Pressure GuagesGalemed Corp. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K862830 | Models 2R and 3R Pneupac Ventilator/Resuscitator | Pneupac, Ltd. | 1986 | — |
| −6 | K024344 | Pneuton Ventilator | Airon Corporation | 2003 | — |
| −5 | K043085 | Modification to: Pneuton Ventilator | Airon Corporation | 2004 | — |
| −4 | K080692 | Macs Cpap System | Airon Corporation | 2008 | — |
| −3 | K092085 | Ispira Resuscitation Unit | Neoforce Group, Inc. | 2009 | — |
| −2 | K102649 | Neopop Infant Resuscitator with Flow Meter | Neoforce Group, Inc. | 2011 | — |
| −1 | K110119 | Pressure Manometer | Neoforce Group, Inc. | 2011 | — |
| 0 (this device) | K122627 | Gio Digital Pressure Guages | Galemed Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1987 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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 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? (4)
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 |
|---|---|---|---|
| * | K904935 | Respironics' Digital ManometerSummary page 1…ulation Number: 868.2600 Device Class 2 18.3 Substantially equivalent to: The Gio Digital Monometer is equivalent to Respironics' pressure manometer (K904935). Other related predicate device: 510(k) Device Name Type Pressure Ran… | 1991 |
| Kept off the family tree | K08178 | NS Series Airway Pressure Monitors Number could not be read Summary page 1…' pressure manometer (K904935). Other related predicate device: 510(k) Device Name Type Pressure Ranges K08178 NS Series Airway Pressure Monitors Balanced Spring 0 -60 cm H120 K992 101 Criterion 40… | |
| * | K992101 | Criterion 40 or PM 40Summary page 1…ce Name Type Pressure Ranges K08178 NS Series Airway Pressure Monitors Balanced Spring 0 -60 cm H120 K992 101 Criterion 40 Digital Manometer 5 -99 cm H120 KI 10119 NF-009 Pressure Manometer… | 2000 |
| * | K110119 | Pressure Manometer | 2011 |
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?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 26 ancestors has a 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. 2013, this device’s year, is highlighted.
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 Gic Digital Manometer is intended for used on all patient populations to measure airway pressure in respiratorycare devices used in the hospital, and post hospital envirnments. It may be attached by flexible, tubing to devices e.g. resuscitation bags; hyperinflation bags, CPAP Masks or Circuits.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122627: Gio Digital Pressure Guages.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122627
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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