Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Novo Nordisk, Inc. · Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

121 daysmedian FDA review time

260 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K231255	NovoFine® Plus	Novo Nordisk, Inc.	2023-08-25	116
K210258	NovoFine	Novo Nordisk, Inc.	2021-06-23	142
K202005	NovoFine Plus 32G Tip x 4 mm	Novo Nordisk, Inc.	2020-12-19	151
K182387	NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Inject	Novo Nordisk, Inc.	2018-12-17	104
K173479	NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)	Novo Nordisk, Inc.	2018-01-17	65
K162602	NovoPen Echo	Novo Nordisk, Inc.	2016-10-18	29
K150874	NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Inject	Novo Nordisk, Inc.	2015-07-31	121
K133738	NOVOFINE PLUS 32G 4 MM	Novo Nordisk, Inc.	2014-05-21	163
K123766	NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN	Novo Nordisk, Inc.	2013-08-15	251
K093109	NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5	Novo Nordisk, Inc.	2010-06-18	260
K090111	FLEXPEN NEEDLE	Novo Nordisk, Inc.	2010-02-01	381
K062500	FLEXPEN NEEDLE	Novo Nordisk, Inc.	2006-11-21	88
K053470	NOVOFINE 32G TIP	Novo Nordisk, Inc.	2005-12-21	7
K050106	NOVOFINE AUTOCOVER 30G X 8MM	Novo Nordisk, Inc.	2005-03-30	71

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda