Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Terumo Europe N.V. — Predicate Candidate Screening

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

88 daysmedian FDA review time

220 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K251447	K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525R	Terumo Europe N.V.	2025-07-08	60	0
K243309	27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)	Terumo Europe N.V.	2025-05-29	220	0
K243581	K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)	Terumo Europe N.V.	2025-04-04	141	0
K230951	Terumo Injection Filter Needle (NF-3013RBKE05M)	Terumo Europe N.V.	2023-10-18	197	0
K212095	SurGuard3 Safety Hypodermic Needle	Terumo Europe N.V.	2022-08-22	412	0
K192057	K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Nee	Terumo Europe N.V.	2019-10-11	71	0
K161606	Syringe with fixed needle - For use only with GONAL-F Multi-	Terumo Europe N.V.	2017-02-10	245	0
K151398	K-Pack II Needle - 29G x 5/16 Thin Wall	Terumo Europe N.V.	2015-06-25	30	0
K150263	K-Pack II Needle-21G x 2	Terumo Europe N.V.	2015-04-01	56	0
K133894	SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (	Terumo Europe N.V.	2014-03-18	88	1
K133867	SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD	Terumo Europe N.V.	2014-02-05	47	0
K132233	K-PACK II NEEDLE - 27G X 3/4 THIN WALL	Terumo Europe N.V.	2013-09-06	50	0
K111797	27 G X 1/2 K-PACK SURSHIELD NEEDLE	Terumo Europe N.V.	2011-09-22	90	0
K110850	K-PACK II NEEDLE- 27G & 30G THIN WALL	Terumo Europe N.V.	2011-06-09	73	0
K110527	K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE	Terumo Europe N.V.	2011-06-06	102	0
K100946	INTRAVSCULAR ADMINISTRATION SET	Terumo Europe N.V.	2010-08-02	118	0
K083514	TERUMO SYRINGE WITH/WITHOUT NEEDLE	Terumo Europe N.V.	2009-05-22	177	0
K082820	K-PACK II NEEDLE - 29G THIN WALL	Terumo Europe N.V.	2008-10-23	28	0
K072894	SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD	Terumo Europe N.V.	2007-11-06	26	0
K070264	50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDI	Terumo Europe N.V.	2007-05-29	120	0
K070547	SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION	Terumo Europe N.V.	2007-05-25	88	0
K070362	SURFLO WINGED INFUSION SET	Terumo Europe N.V.	2007-05-07	89	0
K062608	29G AND 30G K-PACK II NEEDLE	Terumo Europe N.V.	2006-09-15	10	0
K053413	TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES	Terumo Europe N.V.	2006-04-06	120	0
K052887	SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD	Terumo Europe N.V.	2005-12-08	56	0
K041358	VENOJECT LUER ADAPTER	Terumo Europe N.V.	2004-05-28	7	0
K001572	NEOLUS NEEDLE	Terumo Europe N.V.	2000-08-14	84	0
K984576	K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PA	Terumo Europe N.V.	1999-06-14	173	0

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