FDA product code · Cardiovascular

Percutaneous Atrial Catheter Kit

Name: FDA decisions, review times, recalls and adverse event reports for product code OFK
Creator: 510(k) Report

OFKClass II21 CFR 870.12500 decisions2 recalls

0 FDA decisions. 2 recalls name this code, 2 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 www.Fda.Gov/cdrh/ode/convkit.Html. 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 it meets all criteria in the guidance.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, cardiovascular panel

Twenty years of OFK 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 · OFK

FDA has decided no OFK device since 2007.

Median 510(k) review, days · OFK

Too few OFK 510(k)s in any year since 2007 to give a median.

Recalls per year · OFK

2so far in 2026, the most since 2007

2007high 2 (2026) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · OFK

11in 2025

2007high 11 (2025) · low 0 (2007)2025

MAUDE reports naming product code OFK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	1
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	11
2026	—	2 (2)	—

FIG. 1 — OFK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OFK? 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) Report

Related product codes

Other codes under 21 CFR 870.1250.

NTE Temporary Carotid Catheter For Embolic Capture DQY Catheter, Percutaneous PNO Catheter, Percutaneous, Cutting/Scoring PDU Catheter For Crossing Total Occlusions NFA Temporary Coronary Saphenous Vein Bypass Graft…PPN Percutaneous Catheter, Ultrasound NMM Catheter, Angioplasty, Peripheral…NRY Catheter, Thrombus Retriever NVM Catheter, Angioplasty, Peripheral…LIT Catheter, Angioplasty, Peripheral, Transluminal QJP Catheter, Percutaneous, Neurovasculature OMZ Pulmonary (Pulmonic) Valvuloplasty…

Percutaneous Atrial Catheter Kit

What has been recalled in OFK lately?

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