← Product Code [BZH](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH) · K963095 # TRUPEAK PEAK FLOW METER (K963095) _Monaghan Medical Corp. · BZH · Nov 4, 1996 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K963095 ## Device Facts - **Applicant:** Monaghan Medical Corp. - **Product Code:** [BZH](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH.md) - **Decision Date:** Nov 4, 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 peak flow meter; measures Peak Expiratory Flow Rate (PEFR). User places inlet in mouth; performs forced exhalation from full lungs. Internal piston extends spring against pressure spike; indicator moves to maximum displacement position. Indicator remains at peak position for reading on logarithmic scale (liters per minute). Provides higher resolution at lower PEFR readings. Used by patients for self-monitoring or clinicians for assessment. Output informs respiratory status and clinical decision-making. ## Clinical Evidence No clinical data; bench testing only to verify conformance to November 1994 ATS Standards. ## Technological Characteristics Mechanical device; internal piston and spring mechanism. Logarithmic scale for PEFR quantification. Dimensions modified to meet November 1994 ATS Standards. ## Regulatory Identification A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate. ## Predicate Devices - TruPeak Peak Flow Meter ([K955234](/device/K955234.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} K963095 NOV 4 1996 # 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:** July 23, 1996 **Device Proprietary Name:** TruPeak Peak Flow Meter **Device Classification name:** Peak Flow Meter for Spirometry, 73 BZH **Legally Marketed Device Identity:** TruPeak Peak Flow Meter, 510(k) #955234 **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 TruPeak Peak Flow Meter as described in its 510(k) #955234 except for changes in component dimensions necessary for the performance of the device to conform to the November 1994 ATS Standards update. --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K963095](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K963095) **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. 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