← Product Code [FOG](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG) · K962182 # BURLEW INFANT HOOD (K962182) _Promedic, Inc. · FOG · Jul 15, 1996 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG/K962182 ## Device Facts - **Applicant:** Promedic, Inc. - **Product Code:** [FOG](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG.md) - **Decision Date:** Jul 15, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5700 - **Device Class:** Class 1 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic, Pediatric ## Indications for Use The device indicated for patients who need to be placed in an oxygen enriched environment. ## Device Story Disposable infant hood with flexible drape; provides oxygen-enriched environment for neonates/pediatrics. Used in hospitals, neonatal/pediatric ICUs, respiratory therapy, and transport isolettes/incubators. Device features rigid hood (Plexiglas/polycarbonate) and flexible PVC drape; collapsible for storage; includes oxygen source fittings and removable panel for patient access. Clinicians place patient within hood to facilitate oxygen delivery. Benefits include controlled oxygen environment and ease of patient access. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Materials: Plexiglas/polycarbonate hood, PVC drape. Design: Rigid hood with flexible drape, oxygen source fittings, removable access panel, collapsible form factor. Single-patient use. ## Regulatory Identification A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods. ## Predicate Devices - Nova Health Systems ([K893713](/device/K893713.md)) - Sunnydale (K# unknown) - Utah Medical Disposa-Hood (K# unknown) ## 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} K962182 ProMedic, Inc. JUL 15 1996 Non-Confidential Summary of Safety and Effectiveness June 3, 1996 page 1 of 3 ProMedic, Inc. Tel - 317-335-3780 6329 W. Waterview Ct. Fax - 317-335-9270 McCordsville, IN 46055 Official contact: Paul Dryden, President Proprietary or Trade Name: Burlew Infant Hood Common/Usual Name: Infant hood Classification Name: 73 BYL or FOG - Infant oxygen tent / hood Subsection 868.5700 Intended device: Disposable Infant hood with drape Predicate devices: Nova Health Systems - K893713 Sunnydale - K# unknown Utah Medical - Disposa-Hood - K# unknown Device description: Indicated use: The device indicated for patients who need to be placed in an oxygen enriched environment. Target Population: Neonates and pediatrics Environment of use: Hospital, ICU ( neonatal and pediatric), respiratory therapy and transport isolettes / incubators page 3 of 23 6329 W. Waterview Court • McCordsville, IN 46055-9501 317-335-3780 • 317-335-9270 Fax {1} Non-Confidential Summary of Safety and Effectiveness (continued) June 3, 1996 page 2 of 3 Comparison to predicate devices: | Attribute | Burlew Intended device | Nova / Sunnydale Tent | Utah Medical Disposa-Hood | | --- | --- | --- | --- | | Use | | | | | Intended for use with patient for an oxygen rich environment | Yes | Yes | Yes | | Intended for use in RT | Yes | Yes | Yes | | Indicated for use in ICU | Yes | Yes | Yes | | Intended to be used in transport | Yes | No | No | | Indicated for single patient use | Yes | Yes | Yes | | Indicated for use with neonate and pediatric | Yes | Yes | Yes | | Design | | | | | Clear patient area | Yes | Yes | Yes | | Fittings for connection to oxygen source | Yes | Yes | Yes | | Different sizes | Yes | Yes | Yes | | Flexible drape to cover patient | Yes | Yes | No | | Collapsible for easy storage | Yes | No | No | | Panel removable for easy patient access | Yes | Yes | No | | Materials | | | | | Plexiglas / polycarbonate hood | Yes | No | Yes | | PVC drape | Yes | Yes | No | | Performance Testing | | | | | None applicable | Yes | Yes | Yes | page 4 of 23 {2} Non-Confidential Summary of Safety and Effectiveness (continued) June 3, 1996 page 3 of 3 ## Differences The only difference in the intended device is that it incorporates the feature of the two predicate into one device - a rigid patient hood and flexible body drape. Any other differences that do exist would not have a significant effect on the safety or effectiveness of the device. page 5 of 23 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG/K962182](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG/K962182) **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