Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Instrumentation Industries, Inc. · Predicate Candidate Screening
45 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
229 days90th percentile
45clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180510 | NS 120P-TRS Airway Pressure Gauge | Instrumentation Industries, Inc. | 2019-05-01 | 428 | 0 |
| K162753 | RTC 26-C Inline Aerosol Adapter | Instrumentation Industries, Inc. | 2017-02-28 | 151 | 0 |
| K113644 | PILOT TUBE REPAIR KIT | Instrumentation Industries, Inc. | 2012-01-26 | 45 | 0 |
| K102127 | ENDOTRACHEAL TUBE CHANGERS | Instrumentation Industries, Inc. | 2010-08-27 | 29 | 0 |
| K101857 | RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V | Instrumentation Industries, Inc. | 2010-07-22 | 20 | 0 |
| K091111 | RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL | Instrumentation Industries, Inc. | 2009-12-02 | 229 | 0 |
| K081778 | NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS | Instrumentation Industries, Inc. | 2008-09-12 | 81 | 0 |
| K081693 | NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS | Instrumentation Industries, Inc. | 2008-09-11 | 86 | 0 |
| K991355 | METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE | Instrumentation Industries, Inc. | 2000-01-27 | 283 | 0 |
| K992670 | OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 | Instrumentation Industries, Inc. | 1999-09-17 | 88 | 0 |
| K991785 | MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET | Instrumentation Industries, Inc. | 1999-08-17 | 84 | 2 |
| K983631 | AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P | Instrumentation Industries, Inc. | 1999-07-01 | 259 | 0 |
| K981249 | METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED | Instrumentation Industries, Inc. | 1998-11-23 | 231 | 0 |
| K980725 | EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS | Instrumentation Industries, Inc. | 1998-08-24 | 181 | 0 |
| K973066 | NON-REBREATHING 'T' (BE 117) | Instrumentation Industries, Inc. | 1998-02-03 | 169 | 0 |
| K973755 | PILOT TUBE REPAIR KIT | Instrumentation Industries, Inc. | 1997-12-17 | 76 | 0 |
| K970780 | ONE-WAY VALVE (WITH CONNECTOR) | Instrumentation Industries, Inc. | 1997-09-18 | 198 | 0 |
| K970959 | INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT) | Instrumentation Industries, Inc. | 1997-06-13 | 88 | 0 |
| K963347 | REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 | Instrumentation Industries, Inc. | 1997-03-19 | 205 | 0 |
| K884927 | BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER | Instrumentation Industries, Inc. | 1989-06-23 | 207 | 0 |
| K884638 | BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR | Instrumentation Industries, Inc. | 1988-11-23 | 16 | 0 |
| K872316 | BC 1400 HAND POSITIONER | Instrumentation Industries, Inc. | 1987-08-12 | 56 | 0 |
| K872317 | BC 1800 FINGER POSITIONER | Instrumentation Industries, Inc. | 1987-08-12 | 56 | 0 |
| K872319 | LN 100 BREAST MARKER | Instrumentation Industries, Inc. | 1987-08-11 | 55 | 0 |
| K863517 | FOLEY CATHETERS | Instrumentation Industries, Inc. | 1986-10-31 | 52 | 0 |
| K862933 | ABC-1000 SMALL JOINT REAMERS | Instrumentation Industries, Inc. | 1986-08-18 | 14 | 0 |
| K860077 | SG-066 OXYGEN ENRICHMENT KIT | Instrumentation Industries, Inc. | 1986-02-18 | 41 | 0 |
| K831486 | SC-603 TWIN VALVE | Instrumentation Industries, Inc. | 1983-08-12 | 94 | 0 |
| K830475 | BRAIN MODULE RJ-Z10 | Instrumentation Industries, Inc. | 1983-06-08 | 113 | 0 |
| K830898 | SYRINGE 500BC BE #7000 | Instrumentation Industries, Inc. | 1983-05-16 | 56 | 0 |
| K823481 | BE #16 - MANIFOLD | Instrumentation Industries, Inc. | 1982-12-22 | 29 | 0 |
| K823408 | BE#1000-INSTANT ON/OFF O2 VALVE | Instrumentation Industries, Inc. | 1982-12-07 | 22 | 0 |
| K822831 | RI 300 DIFFERENTIAL TEMPERATURE MONITOR | Instrumentation Industries, Inc. | 1982-10-28 | 37 | 0 |
| K822608 | MK 808 SERIES NASAL OXYGEN SAMPLER | Instrumentation Industries, Inc. | 1982-10-04 | 35 | 0 |
| K821492 | BE#6006 VAR. RESIS. INSPIR. MUSCLE | Instrumentation Industries, Inc. | 1982-09-24 | 129 | 0 |
| K810679 | MS-303-OXYGEN REGULATOR SHIELD | Instrumentation Industries, Inc. | 1981-04-17 | 35 | 0 |
| K810348 | CM 3 | Instrumentation Industries, Inc. | 1981-02-23 | 13 | 0 |
| K770631 | FLEX ARM BE 122, CLAMP 122-27 | Instrumentation Industries, Inc. | 1977-05-23 | 49 | 0 |
| K770628 | CLAMP BE-152 | Instrumentation Industries, Inc. | 1977-05-23 | 49 | 0 |
| K770630 | ADAPTER, UNIVERSAL, BE 105-6 | Instrumentation Industries, Inc. | 1977-05-23 | 49 | 0 |
| K770627 | ADAPTER, VALVE, ONE WAY BE-130-22 | Instrumentation Industries, Inc. | 1977-05-23 | 49 | 0 |
| K770629 | VALVE, EXHALATION BE 115-4, 115-5 | Instrumentation Industries, Inc. | 1977-05-23 | 49 | 0 |
| K770633 | BRACKET BE 122-1 | Instrumentation Industries, Inc. | 1977-05-23 | 49 | 0 |
| K770634 | ADAPTER BE 105-101 & 125-101 | Instrumentation Industries, Inc. | 1977-04-08 | 4 | 0 |
| K770632 | GAS COLLHCTOR BE 155(155-2-3,154-4) | Instrumentation Industries, Inc. | 1977-04-08 | 4 | 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