510(k) Report

FDA product code · Clinical chemistry

Thermocycler, Generic

OULClass I21 CFR 862.2310510(k) exempt0 decisions0 recalls

FDA lists OUL as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

A thermocycler is an automated laboratory apparatus intended to amplify specific segments of double stranded nucleic acids isolated from a clinical sample via the polymerase chain reaction process. The nucleic acid sequences are amplified in the presence of specific primers, buffers, and thermostable polymerases, by raising and lowering the thermal block temperature at specific rates using pre-programmed steps…

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, clinical chemistry panel

Twenty years of OUL 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 · OUL

FDA has decided no OUL device since 2007.

Median 510(k) review, days · OUL

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

Recalls per year · OUL

No recall names OUL since 2007.

Adverse event reports per year · OUL

4in 2016

2014: 22016: 4
2007high 4 (2016) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—02
20150—00
20160—04
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OUL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OUL? 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 862.2310.

JJH Clinical Sample ConcentratorPEG Nucleic Acid Quantitation Kit