← Product Code [CAD](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAD) · K960944 # PPV VAPORIZER (MODIFICATION) (K960944) _Penlon , Ltd. · CAD · Apr 2, 1996 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAD/K960944 ## Device Facts - **Applicant:** Penlon , Ltd. - **Product Code:** [CAD](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAD.md) - **Decision Date:** Apr 2, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5880 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## Device Story Penlon PPV Vaporizers are anesthesia delivery devices used to vaporize anesthetic agents. Device incorporates safety features to prevent incorrect or overfilling, including an air lock, agent-specific fillers, a visual level indicator, and an overspill passage. Operated by clinicians in clinical settings to deliver precise concentrations of anesthetic agents to patients. ## Clinical Evidence Bench testing only; compliance with ASTM F1161:1988 Clause 12 verified via testing of sample vaporizers. ## Technological Characteristics Anesthesia vaporizer; features agent-specific fillers, air lock, and overspill protection. Complies with ASTM F1161:1988 Clause 12. ## Regulatory Identification An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient. ## 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} Your Ref: Our Ref: Penlon Inter Med K960944 # ATTACHMENT 5 APR - 2 1990 Penlon Limited Radley Road Abingdon Oxon OX14 3PH Telephone: Abingdon (01235) 554222 Fax: (01235) 555252 Sales Fax: (01235) 555900 Telex Agency: 826715 AERO G Cables: Penlon Abingdon # SUMMARY OF SAFETY AND EFFECTIVENESS This 510(K) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, and in connection with our supplement in respect of the Penlon PPV Vaporizers. 1. Compliance With Standards We confirm that sample vaporizers have been subjected to the tests listed in ASTM F1161:1988 Clause 12, and have been shown to comply with this standard. We also confirm that the test equipment and test conditions used complied with Clause 4 of this standard. The User Manual has been examined and contains the information required by the above standard. 2. An appendix to the hazard analysis has been performed on the design, based on study of literature and evaluation reports, together with in-house experience covering more than 30 years' manufacture and marketing of vaporizers. 3. The test work to show compliance with ASTM F1161:1988 Clause 12 has been extended to cover the external influences noted during the hazard analysis appendix and the results are incorporated as WARNINGS, Caution or Information in the User Manual (a) Vaporizer filling instructions clarification 12.1.13 4. Incorrect and overfilling protection is provided by the combination of (a) an air lock; (b) agent specific fillers; (c) level indicator with visual indication; (d) an overspill passage open during filling. . . . /2 Registered Office: Silvertown House Vincent Square {1} - 2 - ## Attachment 5 cont'd We certify that this summary only includes information which is included in the 510(K) supplement submission. for PENLON LIMITED Alan Clemen Alan C Green Technical Director 6 Feb 1996 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAD/K960944](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAD/K960944) **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