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

Salter Labs — Predicate Candidate Screening

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

70 daysmedian FDA review time

281 days90th percentile

49clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K261389	PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)	Salter Labs	2026-07-30	93	0
K161719	Salter Labs Bubble Humidifier	Salter Labs	2017-09-21	456	0
K151874	BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/	Salter Labs	2016-04-15	281	0
K151506	Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Ca	Salter Labs	2016-03-11	281	0
K151421	Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 O	Salter Labs	2016-03-10	287	0
K143700	CPAP Cannulaide	Salter Labs	2015-08-05	224	0
K142416	Luma Wrap	Salter Labs	2015-06-12	288	0
K092685	PNEUMOTHERML, MODEL: 5800	Salter Labs	2009-11-24	83	0
K051313	BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER	Salter Labs	2005-09-15	119	0
K040202	SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM	Salter Labs	2005-03-04	400	0
K014056	SALTER LABS MODIFIED NEBUTECH NEBULIZER	Salter Labs	2002-02-01	53	0
K992285	SALTER AIRE COMPRESSOR	Salter Labs	2000-01-07	184	0
K992986	SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER	Salter Labs	1999-09-24	21	0
K991788	SALTER LABS PEP DEVICE	Salter Labs	1999-08-06	73	0
K990678	PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)	Salter Labs	1999-05-07	66	0
K983403	SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER	Salter Labs	1998-12-17	81	0
K962879	SALTERLABS 8660 SERIES NEBULIZER	Salter Labs	1996-10-22	90	1
K962085	SALTER LABS 8990 SERIES NEBULIZER	Salter Labs	1996-08-26	89	0
K961476	SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)	Salter Labs	1996-07-16	89	1
K912434	SALTER LABS INFANT NASAL CPAP CANNULA	Salter Labs	1991-07-30	57	0
K912174	SALTER LABS DISPOSABLE NIPPLE AND NUT	Salter Labs	1991-07-24	69	0
K911740	SALTER LABS NEONATAL NASAL OXYGEN CANNULA	Salter Labs	1991-07-24	98	0
K912633	SALTER LABS INFANT MEDIUM CONCENTRATION MASK	Salter Labs	1991-07-19	35	0
K903539	SALTER LABS MODEL #1015	Salter Labs	1990-12-17	132	0
K894350	SALTER LABS MODEL #4009 SAMPLE LINES	Salter Labs	1989-10-03	81	1
K892407	MODIFIED DEMAND NASAL OXYGEN CANNULA	Salter Labs	1989-07-24	108	0
K892406	MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA	Salter Labs	1989-07-24	108	3
K890298	DEMAND NASAL OXYGEN CANNULA MODELS 4008/4108/4208	Salter Labs	1989-02-23	35	0
K884947	HAND HELD NEBULIZER SYSTEM	Salter Labs	1989-02-17	84	1
K881663	OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES	Salter Labs	1988-08-19	126	0
K881473	SL01 OXYGEN ANALYZER	Salter Labs	1988-06-16	70	0
K881472	SL02 OXYGEN ANALYZER	Salter Labs	1988-06-16	70	0
K870027	HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER	Salter Labs	1987-03-16	70	1
K870755	CHALLENGER DOSIMETER	Salter Labs	1987-03-16	18	0
K864199	SALTER LABS #4001 ORAL NASAL CO2 SAMPLING CANNULA	Salter Labs	1987-02-10	106	0
K865047	SALTER LABS #4004/4104 OXYGEN MASK W/C02 SAMP LINE	Salter Labs	1987-02-10	48	0
K864903	MOD. 4006 ADU., OXY. DELIVE.-ORAL CO2 SAM. CANNULA	Salter Labs	1987-01-30	46	0
K864902	MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU.	Salter Labs	1987-01-28	44	0
K865046	SALTER LABS MODEL #4005 GAS SAMPLING TEE AND LINE	Salter Labs	1987-01-15	22	0
K863883	MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA	Salter Labs	1986-10-27	21	0
K863657	OXYGEN CONSERVATOR	Salter Labs	1986-10-15	27	0
K863703	SALTER LABS MODEL 4000 NASAL CO2 SAMPLE LINE	Salter Labs	1986-10-15	22	0
K863659	FLOW INTERRUPTION INDICATOR	Salter Labs	1986-10-15	27	0
K863658	SALTER LABS 3000 SERIES PERCUSSORS	Salter Labs	1986-10-06	18	0
K863656	SALTER VOLUCHEK 6600	Salter Labs	1986-10-06	18	0
K863432	OXYGEN CANNULA EAR WRAP (STYLE B)	Salter Labs	1986-09-18	14	0
K863431	OXYGEN CANNULA EAR WRAP (STYLE A)	Salter Labs	1986-09-18	14	0
K840361	OXYGEN ANALYZER 200	Salter Labs	1984-02-17	22	0
K772127	OXYGEN MASK, AIR-ENTRAINMENT	Salter Labs	1978-01-03	53	1

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