FDA product code · General hospital
Anesthesia Breathing Circuit Kit (Adult & Pediatric)
0 FDA decisions. 10 recalls name this code, 9 of them Class I.
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OFP at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · OFP
FDA has decided no OFP device since 2007.
Median 510(k) review, days · OFP
Too few OFP 510(k)s in any year since 2007 to give a median.
Recalls per year · OFP
1in 2020
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · OFP
6in 2025
MAUDE reports naming product code OFP, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 20 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 9 (9) | 1 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 1 | 16 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
Planning a device in OFP? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 868.5240.