← Product Code [BZH](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH) · K955234 # TRUPEAK PEAK FLOW METER (K955234) _Monaghan Medical Corp. · BZH · Mar 18, 1996 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K955234 ## Device Facts - **Applicant:** Monaghan Medical Corp. - **Product Code:** [BZH](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH.md) - **Decision Date:** Mar 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.1860 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## Indications for Use The TruPeak Peak Flow Meter is a simple mechanical device that responds to and indicates the Peak Expiratory Flow Rate (PEFR) generated by the user during a forced exhalation maneuver. ## Device Story Mechanical device; measures Peak Expiratory Flow Rate (PEFR). User performs forced exhalation into device inlet; internal piston extends spring via pressure spike; indicator moves to maximum displacement position; position corresponds to PEFR value on scale. Logarithmic piston displacement provides higher resolution at lower flow rates. Used by patients for self-monitoring; provides quantitative feedback to assist in respiratory management. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Mechanical peak flow meter; logarithmic piston-spring mechanism; manual indicator; plastic housing; no electronic components; no software; no energy source. ## Regulatory Identification A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate. ## Predicate Devices - TruZone Peak Flow Meter ([K926307](/device/K926307.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} MAR 18 1996 K955235+ # SECTION 2 - SUMMARY AND CERTIFICATION ## 510(k) SUMMARY Monaghan Medical Corporation 5 Latour Ave., Suite 1600 P.O. Box 2805 Plattsburgh, NY 12901-0299 Phone: 518-561-7330 Fax: 518-561-5660 Contact: James A. Cochie QA/RA Manager Date Prepared: October 30, 1995 Device Proprietary Name: TruPeak Peak Flow Meter Device Classification name: Peak Flow Meter for Spirometry, 73 BZH Legally Marketed Device Identity: TruZone Peak Flow Meter, 510(k) #926307 ## Device Description: The TruPeak Peak Flow Meter is a simple mechanical device that responds to and indicates the Peak Expiratory Flow Rate (PEFR) generated by the user during a forced exhalation maneuver. The inlet of the device is placed into the user's mouth after which the maximum rate at exhalation is attempted from nearly full lungs. As this forced exhalation commences an internal piston extends a spring as reaction to an internal pressure spike. An indicator is pushed by the moving piston and remains at the maximum displacement position of the piston after the maneuver is terminated. This position corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. The piston displacement function is logarithmic thereby providing greater resolution of scale at lower PEFR readings. The TruPeak Peak Flow Meter is identical in form and function to the TruZone Peak Flow Meter as described in its 510(k) #926307 except for the use of zone management tapes. The essence of the modification to this 510(k) is changes in the device labeling to conform to the "Guidance for labeling Peak Flow Meters for Over the Counter Sale", dated June 1993. --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K955234](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K955234) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com