FDA product code · Pathology

Formulations, Balanced Salt Solutions

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

KIPClass I21 CFR 864.2875510(k) exempt17 decisions since 19780 recalls

FDA lists KIP as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 864.9 applies, such as a new intended use or a different fundamental technology. 17 FDA decisions since 1978. No recall names this code.

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, pathology panel

Twenty years of KIP 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 · KIP

FDA has decided no KIP device since 2007.

Median 510(k) review, days · KIP

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

Recalls per year · KIP

No recall names KIP since 2007.

Adverse event reports per year · KIP

1in 2017

2007high 4 (2012) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	1
2012	—	4
2013	—	1
2014	—	0
2015	—	0
2016	—	0
2017	—	1
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in KIP? 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

Formulations, Balanced Salt Solutions

What has FDA decided in KIP lately?